{"pressReleaseArticle":{"contentWrapper":{"title":"GSK provides an update on Zejula (niraparib) US prescribing information","intro":"

Issued: London, UK

\r\n

For media and investors only

","publishDateTime":"11/11/2022 00:00:00","publishDate":"11 November 2022","forInvestorsAndMediaOnlyText":"","shortDescription":"Zejula is an oral, once-daily PARP inhibitor currently being evaluated in multiple pivotal trials.","image":null,"downloadLink":null,"tags":[]},"components":[{"type":"rich-text","text":"

GSK plc (LSE/NYSE: GSK) today provided an update that at the request of the US Food and Drug Administration (FDA) it will restrict the second-line maintenance indication for Zejula (niraparib) to only the patient population with deleterious or suspected deleterious germline BRCA mutations (gBRCAmut). The US first-line indication of Zejula remains unchanged for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who have a complete or partial response to platinum-based chemotherapy.

\n

This decision follows an FDA review of the final overall survival (OS) analysis of the ENGOT-OV16/NOVA phase III trial, which served as the basis for the approval of the second-line maintenance indication. In the final OS results from the NOVA trial, the secondary endpoint of OS demonstrated a hazard ratio (HR) of 1.06 (95% CI: 0.81-1.37) in the non-gBRCAmut cohort.  

\n

NOVA is a randomised, double-blind, placebo-controlled phase III trial of niraparib, an oral, once-daily poly (ADP-ribose) polymerase (PARP) inhibitor for the maintenance treatment of women with platinum-sensitive recurrent ovarian cancer. The primary endpoint of the NOVA study was progression-free survival (PFS), evaluated as two independently powered cohorts (gBRCAmut and non-gBRCAmut); results demonstrated the clinically meaningful and statistically significant benefit of niraparib in both cohorts and across the HRD subgroups in the non-gBRCAmut cohort. Secondary endpoints were safety and long-term exploratory endpoints, including overall survival. GSK is in ongoing discussions about these and other emerging OS data with health authorities worldwide.

\n

About ovarian cancer 

\n

Ovarian cancer is the eighth most common cancer in women worldwide.[i] Despite high response rates to platinum-based chemotherapy in the front-line setting, approximately 85% of patients will experience disease recurrence.[ii] Once the disease recurs, it is rarely curable, with decreasing time intervals for each subsequent recurrence. 

\n

About Zejula (niraparib) 

\n

Zejula is an oral, once-daily PARP inhibitor currently being evaluated in multiple pivotal trials. GSK is building a robust clinical development programme by assessing activity across multiple tumour types and evaluating several potential combinations of Zejula with other therapeutics. The ongoing development programme includes several combination studies, including the FIRST phase III trial assessing niraparib in combination with dostarlimab, a programmed death receptor-1 (PD-1)-blocking antibody, as a potential treatment for first-line ovarian cancer maintenance and the phase III ZEAL trial assessing niraparib in combination with standard of care for the maintenance treatment of first line advanced non-small cell lung cancer. GSK also is evaluating niraparib in HER2-negative BRCA-mutated or triple-negative breast cancer. 

\n

Please see accompanying US Prescribing Information.

\n

About GSK

\n

GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at gsk.com/company

\n

Cautionary statement regarding forward-looking statements

\n

GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described in the Company's Annual Report on Form 20-F for 2021, GSK’s Q3 Results for 2022 and any impacts of the COVID-19 pandemic.

\n

 

\n

References

\n

[i] Worldwide Cancer Data. World Cancer Research Fund. https://www.wcrf.org/dietandcancer/cancer-trends/worldwide-cancer-data. Updated January 10, 2022. Accessed July 2022.

\n

[ii] Lorusso D, Mancini M, Di Rocco R, Fontanelli R, Raspagliesi F. The role of secondary surgery in recurrent ovarian cancer [published online August 5, 2012]. Int J Surg Oncol. 2012. doi:10.1155/2012/613980. Accessed September 2022.

","useGreyBackground":false,"fullWidth":false},{"type":"varied-signpost-grid","title":"You might also like","layoutPattern":4,"pages":[{"title":"Media contacts","content":"Access the contact details of our media relations teams at GSK","image":{"src":"/media/jglb0in0/ware_3_2022_prodassmb_30_hess.jpg?width=427&height=533&format=webp&quality=100&v=1dba2ebdfe98900","alt":"Lab worker carrying out tasks","darkModeSrc":"/media/jglb0in0/ware_3_2022_prodassmb_30_hess.jpg?width=427&height=533&format=webp&quality=50&v=1dba2ebdfe98900"},"link":{"text":"Media contacts","href":"/en-gb/media/media-contacts/","openInNewWindowText":null}},{"title":"Media library","content":"Search and download images and B-roll video for use in the media.","image":{"src":"/media/miynibob/gsk_texture_fluid_03_c_cmyk.jpg?width=427&height=533&format=webp&quality=100&v=1dba2ec226de2d0","alt":"Texture fluid graphic","darkModeSrc":"/media/miynibob/gsk_texture_fluid_03_c_cmyk.jpg?width=427&height=533&format=webp&quality=50&v=1dba2ec226de2d0"},"link":{"text":"Media library","href":"/en-gb/media/media-library/","openInNewWindowText":null}},{"title":"Company","content":"We are a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together","image":{"src":"/media/dypld22d/web02-header-immuno_oncology_octane_ry_6k_still-copy.jpg?width=427&height=533&format=webp&quality=100&v=1dba2eba4e6e050","alt":"Immuno Oncology","darkModeSrc":"/media/dypld22d/web02-header-immuno_oncology_octane_ry_6k_still-copy.jpg?width=427&height=533&format=webp&quality=50&v=1dba2eba4e6e050"},"link":{"text":"Company","href":"/en-gb/company/","openInNewWindowText":null}}],"hidePageDescription":false,"useGreyBackground":false}]},"id":6683,"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":"GSK provides an update on Zejula (niraparib) US prescribing information","href":"/en-gb/media/press-releases/gsk-provides-an-update-on-zejula-niraparib-us-prescribing-information/","openInNewWindowText":null}]},"pageName":"GSK provides an update on Zejula (niraparib) US prescribing information","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":"Outstanding people","url":"/en-gb/company/outstanding-people/","nodes":[{"title":"Great place to work","url":"/en-gb/company/outstanding-people/great-place-to-work/","nodes":[],"isActive":false},{"title":"Meet our veterans","url":"/en-gb/company/outstanding-people/meet-our-veterans/","nodes":[],"isActive":false},{"title":"Working together","url":"/en-gb/company/outstanding-people/working-together/","nodes":[],"isActive":false},{"title":"My GSK story","url":"/en-gb/company/outstanding-people/my-gsk-story/","nodes":[],"isActive":false},{"title":"Innovating together","url":"/en-gb/company/outstanding-people/innovating-together/","nodes":[],"isActive":false}],"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/company/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":[],"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":"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/company/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.

\n

GSK plc. Registered in England and Wales No. 3888792.

\n

Registered 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":"Zejula is an oral, once-daily PARP inhibitor currently being evaluated in multiple pivotal trials.","og":[{"property":"og:title","content":"GSK provides an update on Zejula (niraparib) US prescribing information"},{"property":"og:description","content":"Zejula is an oral, once-daily PARP inhibitor currently being evaluated in multiple pivotal trials."},{"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/gsk-provides-an-update-on-zejula-niraparib-us-prescribing-information/"}],"twitter":[{"name":"twitter:card","content":"summary_large_image"},{"name":"twitter:site","content":"@gsk"},{"name":"twitter:title","content":"GSK provides an update on Zejula (niraparib) US prescribing information"},{"name":"twitter:description","content":"Zejula is an oral, once-daily PARP inhibitor currently being evaluated in multiple pivotal trials."},{"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/gsk-provides-an-update-on-zejula-niraparib-us-prescribing-information"}]},"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/gsk-provides-an-update-on-zejula-niraparib-us-prescribing-information/"},"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\":\"Zejula is an oral, once-daily PARP inhibitor currently being evaluated in multiple pivotal trials.\",\"mainEntityOfPage\":\"https://www.gsk.com/en-gb/media/press-releases/gsk-provides-an-update-on-zejula-niraparib-us-prescribing-information/\",\"author\":{\"@type\":\"Organization\",\"name\":\"GSK\",\"url\":\"https://www.gsk.com/en-gb/\"},\"datePublished\":\"2022-11-11T07:00:45+00:00\",\"headline\":\"GSK provides an update on Zejula (niraparib) US prescribing information\",\"keywords\":\"Corporate,Research and development,Medicines\",\"articleSection\":\"Press releases\"}"]}}