GSK receives CHMP positive opinion recommending approval of Zejula (niraparib) as first-line monotherapy maintenance treatment for women with platinum-responsive advanced ovarian cancer
For media and investors only
Issued: London, UK
GlaxoSmithKline (GSK) plc today announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending Zejula (niraparib), an oral poly (ADP-ribose) polymerase (PARP) inhibitor, as a first-line maintenance treatment in women with advanced ovarian cancer who responded to platinum-based chemotherapy, regardless of biomarker status.
Dr Axel Hoos, Senior Vice President and Head of Oncology R&D, GSK said: “Only 20% of women with ovarian cancer are currently eligible to be treated with a PARP inhibitor in the first-line maintenance setting. Today’s positive opinion from the CHMP will give all women in response to platinum-based chemotherapy the option to receive Zejula in the maintenance setting, reinforcing our belief in the important role this innovative medicine may play in helping these patients and the physicians working to treat them.”
The CHMP opinion is one of the final steps in the marketing authorisation procedure prior to approval by the European Commission. This opinion follows the expansion of Zejula’s indication in the US with approval by the US Food and Drug Administration earlier this year.
The Type II variation application is based on data from the phase 3 PRIMA study (ENGOT-OV26/GOG-3012), which demonstrated a clinically meaningful progression-free survival benefit of Zejula treatment in the first-line maintenance setting. The PRIMA study enrolled women with newly diagnosed advanced ovarian cancer who responded to first-line treatment with platinum-based chemotherapy, a population with high unmet needs and limited treatment options.
Zejula has the potential to be the first monotherapy PARP inhibitor approved for first-line maintenance treatment following platinum response regardless of BRCA mutational status, addressing a high unmet need in ovarian cancer.
About Ovarian Cancer
In Europe, ovarian cancer is the sixth deadliest cancer among women and more than 65,000 women are diagnosed each year. Most women are diagnosed with advanced (stage III or IV) ovarian cancer and have a five-year survival rate of ~30%. Despite high response rates to platinum-based chemotherapy in the first-line, approximately 85% of women with advanced ovarian cancer will see their disease return. With each recurrence, the time a woman may spend without her cancer progressing until the next recurrence gets shorter.
About Zejula (niraparib)
Niraparib is an oral, once-daily PARP inhibitor that is currently being evaluated in multiple pivotal trials. GSK is building a robust niraparib clinical development programme by assessing activity across multiple tumour types and by evaluating several potential combinations of niraparib with other therapeutics. The ongoing development programme for niraparib includes several combination studies.
GSK in Oncology
GSK is focused on maximising patient survival through transformational medicines. GSK’s pipeline is focused on immuno-oncology, cell therapy, cancer epigenetics and synthetic lethality. Our goal is to achieve a sustainable flow of new treatments based on a diversified portfolio of investigational medicines utilising modalities such as small molecules, antibodies, antibody drug conjugates and cell therapy, either alone or in combination.
Important Information for ZEJULA
Zejula approved indication:
Zejula is indicated as monotherapy for the maintenance treatment of adult patients with advanced epithelial (FIGO Stages III and IV) high-grade ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy.
Important Safety Information
Contraindications: Hypersensitivity to niraparib or to any of the excipients and breast-feeding.
Warnings and precautions: Test complete blood counts weekly for the first month of treatment, followed by monthly monitoring for the next 10 months of treatment and periodically after this time is recommended to monitor for clinically significant changes in any haematologic parameter during treatment. If a patient develops severe persistent haematologic toxicity (thrombocytopenia, anaemia and neutropenia including pancytopenia) that does not resolve within 28 days following interruption, Zejula should be discontinued. Patients with lower body weight or lower baseline platelet count may be at increased risk of Grade 3+ thrombocytopenia. Due to the risk of thrombocytopenia, anticoagulants and medicinal products known to reduce the thrombocyte count should be used with caution. If MDS and/or AML are confirmed while being prescribed Zejula, treatment should be discontinued, and the patient treated appropriately. Hypertension, including hypertensive crisis, has been reported with the use of Zejula. Pre‑existing hypertension should be adequately controlled before starting Zejula treatment. Zejula should be discontinued in case of hypertensive crisis or if medically significant hypertension cannot be adequately controlled with antihypertensive therapy. There have been reports of Posterior Reversible Encephalopathy Syndrome (PRES) in patients receiving Zejula. In case of PRES, it is recommended to discontinue treatment. Patients with galactose intolerance, the Lapp lactase deficiency or glucose galactose malabsorption should not take this medicine. Tartrazine may cause allergic reactions. Paediatric safety and efficacy has not yet been established.
Undesirable effects: The most common serious adverse reactions were thrombocytopenia and anaemia.
Very common (≥1/10): anaemia, thrombocytopenia, nausea, fatigue, constipation, vomiting, headache, insomnia, platelet count decreased, neutropenia, abdominal pain, decreased appetite, diarrhoea, dyspnoea, hypertension, asthenia, dizziness, neutrophil count decreased, cough, arthralgia, back pain, white blood cell count decreased, and hot flush.
Common (≥1/1000 to <1/10): bronchitis, conjunctivitis, leukopenia, hypersensitivity, hypokalemia, anxiety, depression, dysgeusia, tachycardia, hypertension, epistaxis, dry mouth, abdominal distension, mucosal inflammation (including mucositis), stomatitis, photosensitivity, rash, myalgia, oedema peripheral, fatigue, asthenia, Gamma-glutamyl transferase increased, AST increased, blood creatinine increased, ALT increased, blood alkaline phosphatase increased and weight decreased.
Refer to the Zejula Prescribing Information for a full list of adverse events and the complete important safety information.
GSK is a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. For further information please visit www.gsk.com/about-us.
Cautionary statement regarding forward-looking statements
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 under Item 3.D "Risk Factors" in the company's Annual Report on Form 20-F for 2019 and as set out in GSK’s Principal risks and uncertainties” section of the Q2 Results and any impacts of the COVID-19 pandemic.
 Bray F. Global Cancer Statistics 2018: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA: A Cancer Journal for Clinicians, vol. 68, no. 6, 2018, pp. 394–424., doi:10.3322/caac.21492.
 The World Ovarian Cancer Coalition Atlas: Global Trends in Incidence, Mortality and Survival. World Ovarian Cancer Coalition; 2018. https://worldovariancancercoalition.org/wp-content/uploads/2018/10/THE-WORLD-OVARIAN-CANCER-COALITION-ATLAS-2018.pdf. Accessed August 19, 2020.
 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. doiL10.1155/2012/613980.
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