GSK and Genmab A/S announced today that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for Arzerra® (ofatumumab) in combination with chlorambucil for the treatment of patients with chronic lymphocytic leukaemia (CLL) who have not received prior treatment and are inappropriate for fludarabine-based therapy.
","publishDateTime":"13/09/2013 00:00:00","publishDate":"13 September 2013","forInvestorsAndMediaOnlyText":"","shortDescription":"GSK & Genmab A/S announced today that FDA has granted Breakthrough Therapy designation for Arzerra® (ofatumumab) with chlorambucil for CLL","image":null,"downloadLink":null,"tags":[]},"components":[{"type":"rich-text","text":"Issued: London UK
\nGlaxoSmithKline plc (LSE:GSK) and Genmab A/S (OMX: GEN) announced today that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for Arzerra® (ofatumumab) in combination with chlorambucil for the treatment of patients with chronic lymphocytic leukaemia (CLL) who have not received prior treatment and are inappropriate for fludarabine-based therapy. Ofatumumab is not approved or licensed anywhere in the world for use in this treatment setting. Breakthrough Therapy Designation is the newest of the FDA’s programs aimed at accelerating the development and review times of drugs for serious or life-threatening conditions.
\nCLL is the most common form of leukaemia in adults. Based on estimates by the American Cancer Society, CLL will account for more than 15,680 new cases and more than 4,580 deaths in the United States of America alone in 2013. At present, no curative chemotherapy is available.
\nThe Breakthrough Therapy designation was based on the results from an international, multicentre, randomised Phase III clinical trial in more than 400 patients with previously untreated CLL. Headline results from this trial were announced in May 2013 and the full study results have been submitted for presentation at the 2013 American Society of Hematology Annual Meeting in December.
\n“We are exceedingly proud to receive the Breakthrough Therapy designation, the second this year for GSK. This FDA programme is intended to expedite not just the development but also the review of drugs for serious or life threatening conditions.” said Dr. Kathy Rouan, Vice President and Head of Biopharmaceutical Development, GlaxoSmithKline “We are actively working on our submission and look forward to the enhanced regulatory interaction allowed for Breakthrough Therapies.”
\n“Both of Genmab’s lead products, ofatumumab and daratumumab, have now been granted Breakthrough Therapy Designations from the FDA. This designation for ofatumumab reflects Genmab’s mission to create differentiated products aimed at improving the lives of patients suffering from debilitating diseases and for whom existing treatments are inadequate,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.
\nAbout Breakthrough Therapy Designation
\nThe Breakthrough Therapy designation was enacted as part of the 2012 FDA Safety and Innovation Act (FDASIA) and is intended to expedite development and review of drugs to treat serious or life-threatening medical conditions when preliminary clinical evidence demonstrates that the drug may have substantial improvement on at least one clinically significant endpoint over available therapies. Breakthrough Therapy designation includes all the features of the Fast Track designation, as well as more intensive guidance from the FDA on a drug’s clinical development program.
\nAbout ofatumumab
\nOfatumumab is a human monoclonal antibody which targets an epitope on the CD20 molecule encompassing parts of the small and large extracellular loops[i]. Ofatumumab is being developed under a co-development and commercialisation agreement between Genmab and GSK. For Full US Prescribing Information for the approved indication, please visit: http://us.gsk.com/en-us/products/prescription-medicines-and-vaccines/ and visit health.gsk.com for the EU SPC for the approved indication.
\nGlaxoSmithKline – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit www.gsk.com.
\n| \n GlaxoSmithKline Enquiries: \n | \n\n | \n | \n |
| \n UK Media enquiries: \n | \n\n David Mawdsley \n | \n\n +44 (0) 20 8047 5502 \n | \n\n (London) \n | \n
| \n \n | \n\n Simon Steel \n | \n\n +44 (0) 20 8047 5502 \n | \n\n (London) \n | \n
| \n \n | \n\n David Daley \n | \n\n +44 (0) 20 8047 5502 \n | \n\n (London) \n | \n
| \n \n | \n\n Catherine Hartley \n | \n\n +44 (0) 20 8047 5502 \n | \n\n (London) \n | \n
| \n \n | \n\n \n | \n\n \n | \n\n \n | \n
| \n US Media enquiries: \n | \n\n Melinda Stubbee \n | \n\n +1 215 751 2510 \n | \n\n (North Carolina) \n | \n
| \n \n | \n\n Bernadette King \n | \n\n +1 215 751 3632 \n | \n\n (Philadelphia) \n | \n
| \n \n | \n\n Anna Padula \n | \n\n +1 215 751 4271 \n | \n\n (Philadelphia) \n | \n
| \n \n | \n\n Karen Collins \n | \n\n +1 919 483 2527 \n | \n\n (North Carolina) \n | \n
| \n \n | \n\n Stephen Rea \n | \n\n +1 215 751 4394 \n | \n\n (Philadelphia) \n | \n
| \n \n | \n\n | \n | \n |
| \n Analyst/Investor enquiries: \n | \n\n Ziba Shamsi \n | \n\n + 44 (0) 20 8047 3289 \n | \n\n (London) \n | \n
| \n | \n Lucy Budd \n | \n\n +44 (0) 20 8047 2248 \n | \n\n (London) \n | \n
| \n | \n Tom Curry \n | \n\n + 1 215 751 5419 \n | \n\n (Philadelphia) \n | \n
| \n | \n Gary Davies \n | \n\n + 44 (0) 20 8047 5503 \n | \n\n (London) \n | \n
| \n | \n James Dodwell \n | \n\n + 44 (0) 20 8047 2406 \n | \n\n (London) \n | \n
| \n | \n Jeff McLaughlin \n | \n\n + 1 215 751 7002 \n | \n\n (Philadelphia) \n | \n
About Genmab A/S
Genmab is a publicly traded, international biotechnology company specializing in the creation and development of differentiated human antibody therapeutics for the treatment of cancer. Founded in 1999, the company’s first marketed antibody, ofatumumab (Arzerra®), was approved to treat chronic lymphocytic leukemia in patients who are refractory to fludarabine and alemtuzumab after less than eight years in development. Genmab’s validated and next generation antibody technologies are expected to provide a steady stream of future product candidates. Partnering of innovative product candidates and technologies is a key focus of Genmab’s strategy and the company has alliances with top tier pharmaceutical and biotechnology companies. For more information visit www.genmab.com.
Genmab Contact:
Rachel Curtis Gravesen, Senior Vice President, Investor Relations & Communications
T: +45 33 44 77 20; M: +45 25 12 62 60; E: r.gravesen@genmab.com
Forward Looking Statement for Genmab
This Company Announcement contains forward looking statements. The words “believe”, “expect”, “anticipate”, “intend” and “plan” and similar expressions identify forward looking statements. Actual results or performance may differ materially from any future results or performance expressed or implied by such statements. The important factors that could cause our actual results or performance to differ materially include, among others, risks associated with pre-clinical and clinical development of products, uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues, uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render our products obsolete, and other factors. For a further discussion of these risks, please refer to the risk management sections in Genmab’s most recent financial reports, which are available onwww.genmab.com. Genmab does not undertake any obligation to update or revise forward looking statements in this Company Announcement nor to confirm such statements in relation to actual results, unless required by law.
Genmab A/S and its subsidiaries own the following trademarks: Genmab®; the Y-shaped Genmab logo®; the DuoBody™ logo; HuMax®; HuMax-CD20®; DuoBody®, HexaBodyTM and UniBody®. Arzerra® is a registered trademark of the GlaxoSmithKline group of companies.
\n| \n Cautionary statement regarding forward-looking statements | \n
| \n Registered in England & Wales: \nNo. 3888792 \n | \n
| \n \n | \n
| \n Registered Office: \n980 Great West Road \nBrentford, Middlesex \nTW8 9GS \n | \n
[i] Teeling JL, Mackus WJ, Wiegman LJ, van den Brakel JH, Beers SA, French RR, et al. The biological activity of human CD20 monoclonal antibodies is linked to unique epitopes on CD20. J Immunol. 2006;177(1):362–71
","useGreyBackground":false,"fullWidth":false}]},"id":7723,"docCheckLogout":null,"pageType":"pressReleasePage","languageCode":"en-GB","theme":"light","breadcrumb":{"ariaLabel":"Breadcrumb","links":[{"text":"Home","href":"/en-gb/","openInNewWindowText":null},{"text":"Media","href":"/en-gb/media/","openInNewWindowText":null},{"text":"Press releases","href":"/en-gb/media/press-releases/","openInNewWindowText":null},{"text":"FDA grants GSK and Genmab’s Arzerra® (ofatumumab) Breakthrough Therapy designation for previously untreated chronic lymphocytic leukaemia","href":"/en-gb/media/press-releases/fda-grants-gsk-and-genmab-s-arzerra-ofatumumab-breakthrough-therapy-designation-for-previously-untreated-chronic-lymphocytic-leukaemia/","openInNewWindowText":null}]},"pageName":"FDA grants GSK and Genmab’s Arzerra® (ofatumumab) Breakthrough Therapy designation for previously untreated chronic lymphocytic leukaemia","topNav":{"homeLink":{"text":"GSK Homepage","href":"/en-gb/","openInNewWindowText":null},"topBar":{"currentLocation":{"isGlobal":true,"text":"Global"},"languageSelector":{"currentLanguage":null,"currentLanguageMobile":null,"selectableLanguages":[]},"darkModeSwitch":{"text":"Dark mode","tooltipText":"Switch to dark mode to head towards a more sustainable world together. More info
"},"globalSiteLink":null,"locationSelector":{"text":"Change location","href":"/en-gb/locations/","openInNewWindowText":null},"healthCareLink":{"text":"Healthcare professionals","href":"https://www.gskpro.com","target":"_blank","openInNewWindowText":"Opens in a new window"},"contactUs":{"text":"Contact us","href":"/en-gb/contact-us/","openInNewWindowText":null},"search":"Search","backToMain":"Back to main","menu":"Menu","closeMenu":"Close menu","animationsToggleModel":{"enable":true,"activeText":"Pause video","inactiveText":"Play video"}},"nodes":[{"tooltip":null,"hasBorderRight":true,"title":"Behind the Science magazine","url":"/en-gb/behind-the-science-magazine/","nodes":[],"isActive":false,"promos":[]},{"tooltip":null,"hasBorderRight":false,"title":"Company","url":"/en-gb/company/","nodes":[{"title":"Purpose, strategy and culture","url":"/en-gb/company/purpose-strategy-and-culture/","nodes":[],"isActive":false},{"title":"GSK at a glance","url":"/en-gb/company/gsk-at-a-glance/","nodes":[],"isActive":false},{"title":"History and heritage","url":"/en-gb/company/history-and-heritage/","nodes":[],"isActive":false},{"title":"Board of Directors and Executive Committee","url":"/en-gb/company/board-of-directors-and-leadership-team/","nodes":[],"isActive":false},{"title":"Board information","url":"/en-gb/company/board-information/","nodes":[],"isActive":false},{"title":"Governance","url":"/en-gb/company/governance/","nodes":[{"title":"Committees","url":"/en-gb/company/governance/committees/","nodes":[],"isActive":false},{"title":"Shareholders","url":"/en-gb/company/governance/shareholders/","nodes":[],"isActive":false},{"title":"Sarbanes-Oxley Act 2002","url":"/en-gb/company/governance/sarbanes-oxley-act-2002/","nodes":[],"isActive":false},{"title":"Compliance","url":"/en-gb/company/governance/compliance/","nodes":[],"isActive":false}],"isActive":false},{"title":"Policy positions","url":"/en-gb/company/policy-positions/","nodes":[],"isActive":false},{"title":"Codes, standards and reports","url":"/en-gb/company/codes-standards-and-reports/","nodes":[],"isActive":false}],"isActive":false,"promos":[{"text":"Our purpose, strategy and culture","image":{"src":"/media/vvwddvsg/gsk_tech_human_image_6k.jpg?rxy=0.56833333333333336,0.30177514792899407&width=329&height=185&format=webp&quality=100&v=1dba2ec0bc1e680","alt":"GSK Tech Human Image","darkModeSrc":"/media/vvwddvsg/gsk_tech_human_image_6k.jpg?rxy=0.56833333333333336,0.30177514792899407&width=329&height=185&format=webp&quality=50&v=1dba2ec0bc1e680"},"link":{"text":"FEATURED SECTION","href":"/en-gb/company/purpose-strategy-and-culture/","openInNewWindowText":null}},{"text":"Outstanding people","image":{"src":"/media/kgwp0dc5/sddefault-2.jpg?rxy=0.425,0.51807228915662651&width=329&height=185&format=webp&quality=100&v=1dba2eba773f3d0","alt":"Angeles sitting on a sofa in a pink shirt","darkModeSrc":"/media/kgwp0dc5/sddefault-2.jpg?rxy=0.425,0.51807228915662651&width=329&height=185&format=webp&quality=50&v=1dba2eba773f3d0"},"link":{"text":"FEATURED SECTION","href":"/en-gb/careers/outstanding-people/","openInNewWindowText":null}}]},{"tooltip":null,"hasBorderRight":false,"title":"Innovation","url":"/en-gb/innovation/","nodes":[{"title":"Our leading scientists","url":"/en-gb/innovation/our-leading-scientists/","nodes":[{"title":"Dr Tony Wood","url":"/en-gb/innovation/our-leading-scientists/tony-wood/","nodes":[],"isActive":false},{"title":"Dr Sabine Luik","url":"/en-gb/innovation/our-leading-scientists/sabine-luik/","nodes":[],"isActive":false},{"title":"Dr Hesham Ahmed Abdullah","url":"/en-gb/innovation/our-leading-scientists/hesham-abdullah/","nodes":[],"isActive":false},{"title":"Dr Kaivan Khavandi","url":"/en-gb/innovation/our-leading-scientists/kaivan-khavandi/","nodes":[],"isActive":false},{"title":"Dr Christopher Austin","url":"/en-gb/innovation/our-leading-scientists/dr-christopher-austin/","nodes":[],"isActive":false}],"isActive":false},{"title":"Research and development approach","url":"/en-gb/innovation/research-and-development-approach/","nodes":[],"isActive":false},{"title":"Pipeline","url":"/en-gb/innovation/pipeline/","nodes":[],"isActive":false},{"title":"Therapeutic areas","url":"/en-gb/innovation/therapeutic-areas/","nodes":[{"title":"Respiratory, immunology and inflammation","url":"/en-gb/innovation/therapeutic-areas/respiratory-immunology-and-inflammation/","nodes":[],"isActive":false},{"title":"Oncology","url":"/en-gb/innovation/therapeutic-areas/oncology/","nodes":[],"isActive":false},{"title":"HIV","url":"/en-gb/innovation/therapeutic-areas/hiv/","nodes":[],"isActive":false},{"title":"Infectious diseases","url":"/en-gb/innovation/therapeutic-areas/infectious-diseases/","nodes":[],"isActive":false}],"isActive":false},{"title":"Tech","url":"/en-gb/innovation/technologies/","nodes":[{"title":"Post-quantum cryptography","url":"/en-gb/innovation/technologies/post-quantum-cryptography/","nodes":[],"isActive":false}],"isActive":false},{"title":"Clinical trials at GSK","url":"/en-gb/innovation/trials/","nodes":[{"title":"Provision of unapproved medicines for unmet medical needs","url":"/en-gb/innovation/trials/provision-of-unlicensed-medicines-for-unmet-medical-needs/","nodes":[],"isActive":false},{"title":"Data transparency","url":"/en-gb/innovation/trials/data-transparency/","nodes":[],"isActive":false},{"title":"Representative clinical studies","url":"/en-gb/innovation/trials/representative-clinical-studies/","nodes":[],"isActive":false}],"isActive":false},{"title":"Partnering with GSK","url":"/en-gb/innovation/partnerships/","nodes":[{"title":"Supported studies","url":"/en-gb/innovation/partnerships/supported-studies/","nodes":[],"isActive":false}],"isActive":false},{"title":"R&D locations","url":"/en-gb/innovation/rd-locations/","nodes":[],"isActive":false}],"isActive":false,"promos":[{"text":"Behind the science magazine","image":{"src":"/media/ukvllwft/vaccine-manufacturing-production-line-2.jpg?width=329&height=185&format=webp&quality=100&v=1dba2ebb585f130","alt":"Scientist works in a futurist vaccine laboratory for GSK","darkModeSrc":"/media/ukvllwft/vaccine-manufacturing-production-line-2.jpg?width=329&height=185&format=webp&quality=50&v=1dba2ebb585f130"},"link":{"text":"SPOTLIGHT ON","href":"/en-gb/behind-the-science-magazine/","openInNewWindowText":null}},{"text":"Our leading scientists","image":{"src":"/media/45khexa4/tony-16x9.jpg?rxy=0.5733215608441357,0.39891812701082546&width=329&height=185&format=webp&quality=100&v=1dc651e856734f0","alt":"Tony Wood","darkModeSrc":"/media/45khexa4/tony-16x9.jpg?rxy=0.5733215608441357,0.39891812701082546&width=329&height=185&format=webp&quality=50&v=1dc651e856734f0"},"link":{"text":"Featured section","href":"/en-gb/innovation/our-leading-scientists/","openInNewWindowText":null}}]},{"tooltip":null,"hasBorderRight":false,"title":"Products","url":"/en-gb/products/","nodes":[{"title":"Product areas","url":"/en-gb/products/our-product-areas/","nodes":[],"isActive":false},{"title":"Products A-Z","url":"/en-gb/products/products-a-z/","nodes":[],"isActive":false}],"isActive":false,"promos":[{"text":"Innovation","image":{"src":"/media/jxkd3fld/web03-header-stvg_2_2022_port_5_hess_nav.jpg?width=329&height=185&format=webp&quality=100&v=1dba2ebbe22d650","alt":"Lab technician leaning against wall","darkModeSrc":"/media/jxkd3fld/web03-header-stvg_2_2022_port_5_hess_nav.jpg?width=329&height=185&format=webp&quality=50&v=1dba2ebbe22d650"},"link":{"text":"SPOTLIGHT ON","href":"/en-gb/innovation/","openInNewWindowText":null}},{"text":"GSKPro for healthcare professionals ","image":{"src":"/media/xpibjmpq/navthumb_stvg_03_2022_port_32_eagle_orange-1.jpg?width=329&height=185&format=webp&quality=100&v=1dba2ebbe35c210","alt":"Two scientists on orange background","darkModeSrc":"/media/xpibjmpq/navthumb_stvg_03_2022_port_32_eagle_orange-1.jpg?width=329&height=185&format=webp&quality=50&v=1dba2ebbe35c210"},"link":{"text":"FEATURED WEBSITE","href":"https://gskpro.com","target":"_blank","openInNewWindowText":"Opens in a new window"}}]},{"tooltip":null,"hasBorderRight":true,"title":"Responsibility","url":"/en-gb/responsibility/","nodes":[{"title":"Access","url":"/en-gb/responsibility/access/","nodes":[],"isActive":false},{"title":"Global health and health security","url":"/en-gb/responsibility/global-health-and-health-security/","nodes":[{"title":"Global health","url":"/en-gb/responsibility/global-health-and-health-security/global-health/","nodes":[],"isActive":false},{"title":"Health security","url":"/en-gb/responsibility/global-health-and-health-security/health-security/","nodes":[],"isActive":false},{"title":"Using our science for global health","url":"/en-gb/responsibility/global-health-and-health-security/using-our-science-for-global-health/","nodes":[],"isActive":false},{"title":"Improving access to healthcare","url":"/en-gb/responsibility/global-health-and-health-security/improving-access-to-healthcare/","nodes":[],"isActive":false},{"title":"Africa Open Lab","url":"/en-gb/responsibility/global-health-and-health-security/africa-open-lab/","nodes":[],"isActive":false}],"isActive":false},{"title":"Environment","url":"/en-gb/responsibility/environment/","nodes":[{"title":"Climate","url":"/en-gb/responsibility/environment/climate/","nodes":[],"isActive":false},{"title":"Freshwater","url":"/en-gb/responsibility/environment/freshwater/","nodes":[],"isActive":false},{"title":"Land","url":"/en-gb/responsibility/environment/land/","nodes":[],"isActive":false},{"title":"Oceans","url":"/en-gb/responsibility/environment/oceans/","nodes":[],"isActive":false},{"title":"Materials and waste","url":"/en-gb/responsibility/environment/materials-and-waste/","nodes":[],"isActive":false},{"title":"Health system sustainability","url":"/en-gb/responsibility/environment/health-system-sustainability/","nodes":[],"isActive":false}],"isActive":false},{"title":"Inclusion","url":"/en-gb/responsibility/inclusion/","nodes":[],"isActive":false},{"title":"Ethical standards","url":"/en-gb/responsibility/ethical-standards/","nodes":[{"title":"Working with third parties","url":"/en-gb/responsibility/ethical-standards/working-with-third-parties/","nodes":[],"isActive":false},{"title":"Public policy and patient advocacy","url":"/en-gb/responsibility/ethical-standards/public-policy-and-patient-advocacy/","nodes":[],"isActive":false},{"title":"Human rights","url":"/en-gb/responsibility/ethical-standards/human-rights/","nodes":[],"isActive":false},{"title":"Use of animals","url":"/en-gb/responsibility/ethical-standards/use-of-animals/","nodes":[],"isActive":false},{"title":"Engaging with healthcare professionals","url":"/en-gb/responsibility/ethical-standards/engaging-with-healthcare-professionals/","nodes":[],"isActive":false}],"isActive":false},{"title":"Product governance","url":"/en-gb/responsibility/product-governance/","nodes":[],"isActive":false},{"title":"Grants and donations","url":"/en-gb/responsibility/grants-and-donations/","nodes":[],"isActive":false},{"title":"Charitable investments ","url":"/en-gb/responsibility/charitable-investments/","nodes":[],"isActive":false},{"title":"Responsibility reports","url":"/en-gb/responsibility/responsibility-reports/","nodes":[{"title":"Reports archive","url":"/en-gb/responsibility/responsibility-reports/responsibility-reports-archive/","nodes":[],"isActive":false}],"isActive":false}],"isActive":false,"promos":[{"text":"Inclusion","image":{"src":"/media/2u2dowa1/web16-header-stvg_2_2022_port_13_hess_nav.jpg?width=329&height=185&format=webp&quality=100&v=1dba2ebc1b88030","alt":"Lab technician smiling","darkModeSrc":"/media/2u2dowa1/web16-header-stvg_2_2022_port_13_hess_nav.jpg?width=329&height=185&format=webp&quality=50&v=1dba2ebc1b88030"},"link":{"text":"FEATURED SECTION","href":"/en-gb/responsibility/inclusion/","openInNewWindowText":null}},{"text":"Our policy positions","image":{"src":"/media/110ltmz5/gsk_texture_fluid_03_a_cmyk_web-size_nav.jpg?width=329&height=185&format=webp&quality=100&v=1dba2ebbe9b61b0","alt":"GSK orange texture","darkModeSrc":"/media/110ltmz5/gsk_texture_fluid_03_a_cmyk_web-size_nav.jpg?width=329&height=185&format=webp&quality=50&v=1dba2ebbe9b61b0"},"link":{"text":"SPOTLIGHT ON","href":"/en-gb/company/policy-positions/","openInNewWindowText":null}}]},{"tooltip":null,"hasBorderRight":false,"title":"Investors","url":"/en-gb/investors/","nodes":[{"title":"Why invest in GSK?","url":"/en-gb/investors/why-invest-in-gsk/","nodes":[],"isActive":false},{"title":"Quarterly results","url":"/en-gb/investors/quarterly-results/","nodes":[],"isActive":false},{"title":"Financial reports","url":"/en-gb/investors/financial-reports/","nodes":[{"title":"Annual Report 2025","url":"/en-gb/investors/financial-reports/annual-report-2025/","nodes":[],"isActive":false},{"title":"Corporate reports archive","url":"/en-gb/investors/financial-reports/corporate-reports-archive/","nodes":[],"isActive":false}],"isActive":false},{"title":"Responsible business","url":"/en-gb/investors/responsible-business/","nodes":[],"isActive":false},{"title":"Speeches and presentations","url":"/en-gb/investors/speeches-and-presentations/","nodes":[],"isActive":false},{"title":"Science publications","url":"/en-gb/investors/science-publications/","nodes":[],"isActive":false},{"title":"Events calendar","url":"/en-gb/investors/events-calendar/","nodes":[],"isActive":false},{"title":"Dividend and share price","url":"/en-gb/investors/dividend-and-share-price/","nodes":[{"title":"GSK share price","url":"/en-gb/investors/dividend-and-share-price/gsk-share-price/","nodes":[],"isActive":false},{"title":"Share price calculators (GBp/USD)","url":"/en-gb/investors/dividend-and-share-price/share-price-calculators-gbpusd/","nodes":[],"isActive":false},{"title":"Dividend calculators (GBp/USD)","url":"/en-gb/investors/dividend-and-share-price/dividend-calculators-gbpusd/","nodes":[],"isActive":false},{"title":"Dividend calendar","url":"/en-gb/investors/dividend-and-share-price/dividend-calendar/","nodes":[],"isActive":false}],"isActive":false},{"title":"Analyst consensus","url":"/en-gb/investors/analyst-consensus/","nodes":[],"isActive":false},{"title":"Stock exchange announcements","url":"/en-gb/investors/stock-exchange-announcements/","nodes":[{"title":"London (RNS)","url":"/en-gb/investors/stock-exchange-announcements/london-rns/","nodes":[],"isActive":false},{"title":"London (RNS) inside information","url":"/en-gb/investors/stock-exchange-announcements/london-rns-inside-information/","nodes":[],"isActive":false},{"title":"New York (SEC)","url":"/en-gb/investors/stock-exchange-announcements/new-york-sec/","nodes":[],"isActive":false},{"title":"Sign up for announcements","url":"/en-gb/investors/stock-exchange-announcements/sign-up-for-announcements/","nodes":[],"isActive":false}],"isActive":false},{"title":"Shareholder information","url":"/en-gb/investors/shareholder-information/","nodes":[{"title":"Manage your shares","url":"/en-gb/investors/shareholder-information/manage-your-shares/","nodes":[],"isActive":false},{"title":"Annual General Meeting","url":"/en-gb/investors/shareholder-information/annual-general-meeting/","nodes":[],"isActive":false},{"title":"General Meeting","url":"/en-gb/investors/shareholder-information/general-meeting/","nodes":[],"isActive":false},{"title":"Annual Governance Meeting","url":"/en-gb/investors/shareholder-information/annual-governance-meeting/","nodes":[],"isActive":false},{"title":"Corporate sponsored nominee service","url":"/en-gb/investors/shareholder-information/corporate-sponsored-nominee-service/","nodes":[],"isActive":false},{"title":"Our ADR programme","url":"/en-gb/investors/shareholder-information/adr-programme/","nodes":[],"isActive":false},{"title":"Asset reunification - Georgeson ","url":"/en-gb/investors/shareholder-information/asset-reunification-georgeson/","nodes":[],"isActive":false},{"title":"Share scam alert","url":"/en-gb/investors/shareholder-information/share-scam-alert/","nodes":[],"isActive":false},{"title":"Privacy notice for ordinary shareholders","url":"/en-gb/investors/shareholder-information/privacy-notice-for-ordinary-shareholders/","nodes":[],"isActive":false},{"title":"FAQs","url":"/en-gb/investors/shareholder-information/shareholder-faqs/","nodes":[],"isActive":false}],"isActive":false},{"title":"Corporate actions","url":"/en-gb/investors/corporate-actions/","nodes":[{"title":"Consumer Healthcare Demerger","url":"/en-gb/investors/corporate-actions/consumer-healthcare-demerger/","nodes":[],"isActive":false},{"title":"Consumer Healthcare Joint Venture","url":"/en-gb/investors/corporate-actions/consumer-healthcare-joint-venture/","nodes":[],"isActive":false},{"title":"Agreement to acquire TESARO","url":"/en-gb/investors/corporate-actions/agreement-to-acquire-tesaro/","nodes":[],"isActive":false}],"isActive":false},{"title":"Debt investors","url":"/en-gb/investors/debt-investors/","nodes":[],"isActive":false},{"title":"Investor contacts","url":"/en-gb/investors/investor-contacts/","nodes":[],"isActive":false}],"isActive":false,"promos":[{"text":"Press releases","image":{"src":"/media/hb1dfygw/ware_3_2022_prodassmb_28_hess_nav.jpeg?width=329&height=185&format=webp&quality=100&v=1dba2ebc6f12bb0","alt":"Lab machinery","darkModeSrc":"/media/hb1dfygw/ware_3_2022_prodassmb_28_hess_nav.jpeg?width=329&height=185&format=webp&quality=50&v=1dba2ebc6f12bb0"},"link":{"text":"SPOTLIGHT ON","href":"/en-gb/media/press-releases/","openInNewWindowText":null}},{"text":"Our pipeline","image":{"src":"/media/2kyan0vw/ware_3_2022_prodqc_14_hess.jpeg?width=329&height=185&format=webp&quality=100&v=1dba2ebc701f490","alt":"Case of vials","darkModeSrc":"/media/2kyan0vw/ware_3_2022_prodqc_14_hess.jpeg?width=329&height=185&format=webp&quality=50&v=1dba2ebc701f490"},"link":{"text":"SPOTLIGHT ON","href":"/en-gb/innovation/pipeline/","openInNewWindowText":null}}]},{"tooltip":null,"hasBorderRight":false,"title":"Media","url":"/en-gb/media/","nodes":[{"title":"Press releases","url":"/en-gb/media/press-releases/","nodes":[],"isActive":true},{"title":"Media contacts","url":"/en-gb/media/media-contacts/","nodes":[],"isActive":false},{"title":"Media library","url":"/en-gb/media/media-library/","nodes":[],"isActive":false},{"title":"Zantac litigation","url":"/en-gb/media/zantac-litigation/","nodes":[],"isActive":false},{"title":"GSK's position on Flovent","url":"/en-gb/media/gsks-position-on-flovent/","nodes":[],"isActive":false},{"title":"Our social media","url":"/en-gb/media/social-media/","nodes":[],"isActive":false},{"title":"Podcasts","url":"/en-gb/media/podcasts/","nodes":[],"isActive":false},{"title":"RSS feeds","url":"/en-gb/media/rss-feeds/","nodes":[],"isActive":false}],"isActive":true,"promos":[{"text":"Behind the science magazine","image":{"src":"/media/ukvllwft/vaccine-manufacturing-production-line-2.jpg?width=329&height=185&format=webp&quality=100&v=1dba2ebb585f130","alt":"Scientist works in a futurist vaccine laboratory for GSK","darkModeSrc":"/media/ukvllwft/vaccine-manufacturing-production-line-2.jpg?width=329&height=185&format=webp&quality=50&v=1dba2ebb585f130"},"link":{"text":"Spotlight on","href":"/en-gb/behind-the-science-magazine/","openInNewWindowText":null}}]},{"tooltip":null,"hasBorderRight":false,"title":"Careers","url":"/en-gb/careers/","nodes":[{"title":"Search jobs","url":"/en-gb/careers/search-jobs/","nodes":[],"isActive":false},{"title":"Featured careers","url":"/en-gb/careers/featured-careers/","nodes":[{"title":"A career in data","url":"/en-gb/careers/featured-careers/a-career-in-data/","nodes":[],"isActive":false}],"isActive":false},{"title":"Life at GSK","url":"/en-gb/careers/life-at-gsk/","nodes":[],"isActive":false},{"title":"Outstanding people","url":"/en-gb/careers/outstanding-people/","nodes":[{"title":"Great place to work","url":"/en-gb/careers/outstanding-people/great-place-to-work/","nodes":[],"isActive":false},{"title":"Meet our veterans","url":"/en-gb/careers/outstanding-people/meet-our-veterans/","nodes":[],"isActive":false},{"title":"Working together","url":"/en-gb/careers/outstanding-people/working-together/","nodes":[],"isActive":false},{"title":"My GSK story","url":"/en-gb/careers/outstanding-people/my-gsk-story/","nodes":[],"isActive":false},{"title":"Innovating together","url":"/en-gb/careers/outstanding-people/innovating-together/","nodes":[],"isActive":false}],"isActive":false},{"title":"Experienced professionals","url":"/en-gb/careers/experienced-professionals/","nodes":[{"title":"Business operations","url":"/en-gb/careers/experienced-professionals/business-operations/","nodes":[],"isActive":false},{"title":"Engineering at GSK ","url":"/en-gb/careers/experienced-professionals/engineering/","nodes":[],"isActive":false},{"title":"Global supply chain","url":"/en-gb/careers/experienced-professionals/global-supply-chain/","nodes":[],"isActive":false},{"title":"Sales and marketing","url":"/en-gb/careers/experienced-professionals/sales-and-marketing/","nodes":[],"isActive":false},{"title":"Research and development","url":"/en-gb/careers/experienced-professionals/research-and-development/","nodes":[{"title":"Chemical Manufacturing and Controls (CMC), Medicine Development and Supply (MDS)","url":"/en-gb/careers/experienced-professionals/research-and-development/chemical-manufacturing-and-controls-cmc-medicine-development-and-supply-mds/","nodes":[],"isActive":false},{"title":"Genomic sciences","url":"/en-gb/careers/experienced-professionals/research-and-development/genomic-sciences/","nodes":[],"isActive":false}],"isActive":false},{"title":"Technology","url":"/en-gb/careers/experienced-professionals/technology/","nodes":[],"isActive":false}],"isActive":false},{"title":"Early careers","url":"/en-gb/careers/early-careers/","nodes":[{"title":"Application process","url":"/en-gb/careers/early-careers/application-process/","nodes":[],"isActive":false},{"title":"Apprentice programmes","url":"/en-gb/careers/early-careers/apprentice-programmes/","nodes":[],"isActive":false},{"title":"Internships and placements","url":"/en-gb/careers/early-careers/internships-and-placements/","nodes":[],"isActive":false},{"title":"Graduate programme","url":"/en-gb/careers/early-careers/graduate-programme/","nodes":[{"title":"Business operations","url":"/en-gb/careers/early-careers/graduate-programme/business-operations/","nodes":[],"isActive":false},{"title":"Engineering","url":"/en-gb/careers/early-careers/graduate-programme/engineering/","nodes":[],"isActive":false},{"title":"Manufacturing & supply","url":"/en-gb/careers/early-careers/graduate-programme/manufacturing-supply/","nodes":[],"isActive":false},{"title":"Commercial ","url":"/en-gb/careers/early-careers/graduate-programme/commercial/","nodes":[],"isActive":false},{"title":"Research & development","url":"/en-gb/careers/early-careers/graduate-programme/research-development/","nodes":[],"isActive":false},{"title":"Digital & tech","url":"/en-gb/careers/early-careers/graduate-programme/digital-tech/","nodes":[],"isActive":false},{"title":"Manufacturing sciences & technology","url":"/en-gb/careers/early-careers/graduate-programme/manufacturing-sciences-technology/","nodes":[],"isActive":false}],"isActive":false},{"title":"Post graduate opportunities","url":"/en-gb/careers/early-careers/post-graduate-opportunities/","nodes":[],"isActive":false},{"title":"Frequently asked questions","url":"/en-gb/careers/early-careers/frequently-asked-questions/","nodes":[],"isActive":false}],"isActive":false},{"title":"Veterans","url":"/en-gb/careers/veterans/","nodes":[],"isActive":false},{"title":"Our global and regional hubs","url":"/en-gb/careers/our-global-and-regional-hubs/","nodes":[],"isActive":false},{"title":"How we hire","url":"/en-gb/careers/how-we-hire/","nodes":[{"title":"Fraudulent internet recruitment activities","url":"/en-gb/careers/how-we-hire/fraudulent-internet-recruitment-activities/","nodes":[],"isActive":false},{"title":"Frequently asked questions","url":"/en-gb/careers/how-we-hire/frequently-asked-questions/","nodes":[],"isActive":false}],"isActive":false}],"isActive":false,"promos":[{"text":"Outstanding people","image":{"src":"/media/kgwp0dc5/sddefault-2.jpg?rxy=0.425,0.51807228915662651&width=329&height=185&format=webp&quality=100&v=1dba2eba773f3d0","alt":"Angeles sitting on a sofa in a pink shirt","darkModeSrc":"/media/kgwp0dc5/sddefault-2.jpg?rxy=0.425,0.51807228915662651&width=329&height=185&format=webp&quality=50&v=1dba2eba773f3d0"},"link":{"text":"Spotlight on","href":"/en-gb/careers/outstanding-people/","openInNewWindowText":null}},{"text":"Inclusion","image":{"src":"/media/2u2dowa1/web16-header-stvg_2_2022_port_13_hess_nav.jpg?width=329&height=185&format=webp&quality=100&v=1dba2ebc1b88030","alt":"Lab technician smiling","darkModeSrc":"/media/2u2dowa1/web16-header-stvg_2_2022_port_13_hess_nav.jpg?width=329&height=185&format=webp&quality=50&v=1dba2ebc1b88030"},"link":{"text":"Spotlight on","href":"/en-gb/responsibility/inclusion/","openInNewWindowText":null}}]}],"skipToContent":"Skip to content","skipToSearch":"Skip to search","typeaheadSearch":{"apiEndpoint":"api/search/typeahead?siteContainerId=1703","searchFieldPlaceholderText":"Enter a search term...","searchPage":"/en-gb/search/","ariaLabel":"Submit form"},"ariaLabel":"Global navigation"},"footer":{"logo":null,"copyrightText":"This is our global website, intended for visitors seeking information on GSK's worldwide business. Our market sites can be reached by visiting our location selector.
\n\n
© 2001-2026 GSK plc. All rights reserved. Trade marks are owned by or licensed to the GSK group of companies.
\nGSK plc. Registered in England and Wales No. 3888792.
\nRegistered office: 79 New Oxford Street, London. United Kingdom. WC1A 1DG
","modernSlaveryStatement":{"name":"Modern Slavery Act Statement 2025","url":"/media/5ladhmeu/modern-slavery-act-statement-2025.pdf","fileExtension":"PDF","fileSize":"187.7KB","type":"file","target":"_blank","openInNewWindowText":"Opens in a new window"},"sections":{"socialMedia":{"columnTitle":"Follow us on:","socialMediaItems":[{"globalLink":{"text":null,"href":"http://www.linkedin.com/company/glaxosmithkline","target":"_blank","openInNewWindowText":"Opens in a new window"},"localLink":null,"ariaLabel":"Visit GSK on Linkedin","customIcon":null,"showPopupMenu":false,"type":"LinkedIn"},{"globalLink":{"text":null,"href":"http://twitter.com/GSK","target":"_blank","openInNewWindowText":"Opens in a new window"},"localLink":null,"ariaLabel":"Visit GSK X page","customIcon":null,"showPopupMenu":false,"type":"X"},{"globalLink":{"text":null,"href":"https://bsky.app/profile/gsk.bsky.social/","target":"_blank","openInNewWindowText":"Opens in a new window"},"localLink":null,"ariaLabel":"","customIcon":null,"showPopupMenu":false,"type":"Bluesky"},{"globalLink":{"text":null,"href":"https://www.instagram.com/gsk/","target":"_blank","openInNewWindowText":"Opens in a new window"},"localLink":null,"ariaLabel":"Visit GSK Instagram","customIcon":null,"showPopupMenu":false,"type":"Instagram"},{"globalLink":{"text":null,"href":"https://www.facebook.com/GSK","target":"_blank","openInNewWindowText":"Opens in a new window"},"localLink":null,"ariaLabel":"Visit GSK Facebook page","customIcon":null,"showPopupMenu":false,"type":"Facebook"},{"globalLink":{"text":null,"href":"http://www.youtube.com/GSK","target":"_blank","openInNewWindowText":"Opens in a new window"},"localLink":null,"ariaLabel":"Visit GSK YouTube Channel","customIcon":null,"showPopupMenu":false,"type":"Youtube"},{"globalLink":{"text":null,"href":"/en-gb/media/rss-feeds/","openInNewWindowText":null},"localLink":null,"ariaLabel":"Visit GSK RSS feeds","customIcon":null,"showPopupMenu":false,"type":"Rss"}]},"columns":[{"columnTitle":"GSK websites","links":[{"text":"Locations selector","href":"/en-gb/locations/","openInNewWindowText":null},{"text":"Social media directory","href":"/en-gb/media/social-media/","openInNewWindowText":null},{"text":"GSKPro for healthcare professionals","href":"https://www.gskpro.com","target":"_blank","openInNewWindowText":"Opens in a new window"},{"text":"GSK study register","href":"https://www.gsk-studyregister.com/en/","target":"_blank","openInNewWindowText":"Opens in a new window"},{"text":"Supplier website","href":"https://supplier.gsk.com","target":"_blank","openInNewWindowText":"Opens in a new window"},{"text":"ViiV Healthcare","href":"https://viivhealthcare.com/","target":"_blank","openInNewWindowText":"Opens in a new window"}]},{"columnTitle":"Quick links","links":[{"text":"Behind the Science magazine","href":"/en-gb/behind-the-science-magazine/","openInNewWindowText":null},{"text":"Company","href":"/en-gb/company/","openInNewWindowText":null},{"text":"Innovation","href":"/en-gb/innovation/","openInNewWindowText":null},{"text":"Products","href":"/en-gb/products/","openInNewWindowText":null},{"text":"Responsibility","href":"/en-gb/responsibility/","openInNewWindowText":null},{"text":"Investors","href":"/en-gb/investors/","openInNewWindowText":null},{"text":"Media","href":"/en-gb/media/","openInNewWindowText":null},{"text":"Careers","href":"/en-gb/careers/","openInNewWindowText":null}]},{"columnTitle":"Get in touch","links":[{"text":"Contact us","href":"/en-gb/contact-us/","openInNewWindowText":null},{"text":"Partnerships","href":"/en-gb/innovation/partnerships/","openInNewWindowText":null},{"text":"Report a possible side effect","href":"/en-gb/contact-us/report-a-possible-side-effect/","openInNewWindowText":null},{"text":"GSK Speak up","href":"https://www.gsk.com/speakup","target":"_blank","openInNewWindowText":"Opens in a new window"}]}]},"bottomLinks":[{"text":"Accessibility","href":"/en-gb/accessibility/","openInNewWindowText":null},{"text":"Digital sustainability","href":"/en-gb/digital-sustainability/","openInNewWindowText":null},{"text":"Terms of use","href":"/en-gb/terms-of-use/","openInNewWindowText":null},{"text":"Cookie policy","href":"/en-gb/cookie-policy/","openInNewWindowText":null},{"text":"Privacy notice","href":"https://privacy.gsk.com/en-gb/privacy-notice/general","target":"_blank","openInNewWindowText":"Opens in a new window"},{"text":"Sitemap","href":"/en-gb/sitemap/","openInNewWindowText":null}],"continueToLink":null,"legalApprovalText":""},"sharing":{"description":"GSK & Genmab A/S announced today that FDA has granted Breakthrough Therapy designation for Arzerra® (ofatumumab) with chlorambucil for CLL","og":[{"property":"og:title","content":"FDA grants GSK and Genmab’s Arzerra® (ofatumumab) Breakthrough Therapy designation for previously untreated chronic lymphocytic leukaemia"},{"property":"og:description","content":"GSK & Genmab A/S announced today that FDA has granted Breakthrough Therapy designation for Arzerra® (ofatumumab) with chlorambucil for CLL"},{"property":"og:image","content":"https://www.gsk.com/media/p3clrlre/stvg_2_2022_smtlab_17_hess.jpg?width=600&format=webp&quality=100&v=1dbd496701ca530"},{"property":"og:url","content":"https://www.gsk.com/en-gb/media/press-releases/fda-grants-gsk-and-genmab-s-arzerra-ofatumumab-breakthrough-therapy-designation-for-previously-untreated-chronic-lymphocytic-leukaemia/"}],"twitter":[{"name":"twitter:card","content":"summary_large_image"},{"name":"twitter:site","content":"@gsk"},{"name":"twitter:title","content":"FDA grants GSK and Genmab’s Arzerra® (ofatumumab) Breakthrough Therapy designation for previously untreated chronic lymphocytic leukaemia"},{"name":"twitter:description","content":"GSK & Genmab A/S announced today that FDA has granted Breakthrough Therapy designation for Arzerra® (ofatumumab) with chlorambucil for CLL"},{"name":"twitter:image","content":"https://www.gsk.com/media/p3clrlre/stvg_2_2022_smtlab_17_hess.jpg?width=600&format=webp&quality=100&v=1dbd496701ca530"},{"name":"twitter:url","content":"https://www.gsk.com/en-gb/media/press-releases/fda-grants-gsk-and-genmab-s-arzerra-ofatumumab-breakthrough-therapy-designation-for-previously-untreated-chronic-lymphocytic-leukaemia"}]},"stickyShare":null,"exitSitePreferences":{"popupEnabled":false,"title":"","texts":"","continueText":"Continue","cancelText":"Cancel","exclusionUrls":[]},"settings":{"optionalStylesheetLink":null,"themeColorHexCode":null,"headerLogoLightTheme":null,"headerLogoDarkTheme":null,"footerLogo":{"src":"https://www.gsk.com/media/0jwou3xu/gsk-logo.png?width=104&format=webp&quality=100&v=1dbf4b05a4e6470","alt":"Gsk Logo","darkModeSrc":"https://www.gsk.com/media/0jwou3xu/gsk-logo.png?width=104&format=webp&quality=50&v=1dbf4b05a4e6470"},"scripts":[{"pageLocation":"Top","text":" \n"}],"globalWebsiteLink":null,"googleMapsApiKey":"AIzaSyA2QMg4Ww6djPKb7b9BraQn4kgJmDaLblg","textToSpeechApiKey":"70ab0a79-1d92-4286-86d2-abdd71cc785c","bingVerificationCode":"","googleAnalytics":"","siteTitle":" | GSK"},"pageSettings":{"disableBackToTopButton":false,"backToTopButtonText":"Back to top","robotsNoFollow":false,"robotsNoIndex":false,"canonicalUrl":"https://www.gsk.com/en-gb/media/press-releases/fda-grants-gsk-and-genmab-s-arzerra-ofatumumab-breakthrough-therapy-designation-for-previously-untreated-chronic-lymphocytic-leukaemia/"},"tealiumSettings":{"enabled":false,"data":""},"entryPopup":{"title":"","text":"You are about to access GSK historic archived press release material retained as a corporate record. References to products or their uses may be out of date and not reflect current medical, safety or regulatory information. For clinical information, consult the approved national product label information (SmPC).
","continueText":"Continue","cancelText":"Cancel"},"protectedPage":false,"schema":{"jsonLdSchemas":["{\"@context\":\"https://schema.org\",\"@type\":\"NewsArticle\",\"description\":\"GSK \\u0026 Genmab A/S announced today that FDA has granted Breakthrough Therapy designation for Arzerra\\u00AE (ofatumumab) with chlorambucil for CLL\",\"mainEntityOfPage\":\"https://www.gsk.com/en-gb/media/press-releases/fda-grants-gsk-and-genmab-s-arzerra-ofatumumab-breakthrough-therapy-designation-for-previously-untreated-chronic-lymphocytic-leukaemia/\",\"author\":{\"@type\":\"Organization\",\"name\":\"GSK\",\"url\":\"https://www.gsk.com/en-gb/\"},\"datePublished\":\"2013-09-13T00:00:00+00:00\",\"headline\":\"FDA grants GSK and Genmab\\u2019s Arzerra\\u00AE (ofatumumab) Breakthrough Therapy designation for previously untreated chronic lymphocytic leukaemia\",\"keywords\":\"Research and development,Medicines\",\"articleSection\":\"Press releases\"}"]}}