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ejula (niraparib) / GSK, ZAI Lab, J&J, TakedaU.S. FDA accepts GSK’s sNDA application for Zejula (niraparib) for first-line maintenance treatment for women with platinum-responsive advanced ovarian cancer (GSK Press Release) - Feb 24, 2020 - "GlaxoSmithKline plc...announced that the U.S. Food and Drug Administration (FDA) accepted the company’s submission of a supplemental New Drug Application (sNDA) seeking approval of Zejula (niraparib) as a maintenance treatment in the first-line setting for women with advanced ovarian cancer who responded to platinum-based chemotherapy regardless of biomarker status. The FDA is reviewing the sNDA under the Real-Time Oncology Review (RTOR) pilot program...The application is supported by data from the PRIMA study (ENGOT-OV26/GOG-3012)..."Zejula (niraparib) / GSK, ZAI Lab, J&J, TakedaEuropean Medicines Agency accepts submission of GSK's Marketing Authorisation Application for Zejula (niraparib) in first-line maintenance treatment for women with platinum-responsive advanced ovarian cancer (PRNewswire) - Feb 27, 2020 - "GlaxoSmithKline plc announced that the European Medicines Agency (EMA) has validated the company's Type II Variation (T2V) for Zejula (niraparib) as a maintenance treatment in the first-line setting for women with advanced ovarian cancer who responded to platinum-based chemotherapy regardless of biomarker status. Validation of the T2V confirms that the submission is accepted and begins the formal review process by the EMA's Committee for Human Medicinal Products (CHMP). The submission is based on data from the PRIMA study (ENGOT-OV26/GOG-3012), which demonstrated clinically meaningful outcomes of niraparib treatment in the first-line maintenance setting."Rubraca (rucaparib) / ClovisClovis Oncology announces availability and reimbursement for Rubraca (rucaparib) tablets for women with relapsed ovarian cancer in Spain (Businesswire) - Mar 2, 2020 - “Clovis Oncology, Inc…announced that Rubraca® (rucaparib) is now available and reimbursed in Spain following the Spanish Interministerial Commission on Prices of Medicines and Health Products approval of rucaparib for reimbursement. Rucaparib is now available as an option for monotherapy maintenance treatment for adults with relapsed, platinum-sensitive high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer that has responded to platinum-based chemotherapy…The European Union (EU) authorization is based on data from the pivotal phase 3 ARIEL3 clinical trial…”Nexavar (sorafenib) / Bayer, AmgenNovocure reports fourth quarter and full year 2019 financial results and provides company update (Businesswire) - Feb 27, 2020 - "Anticipated clinical milestones....Interim analysis of phase 3 pivotal LUNAR trial in non-small cell lung cancer (H2 2020); Data from phase 2 pilot HEPANOVA trial in advanced liver cancer (2021); Data from phase 3 pivotal METIS trial in brain metastases (2021); Interim analysis of phase 3 pivotal PANOVA-3 trial in locally advanced pancreatic cancer (2021); Final data from phase 3 pivotal LUNAR trial in non-small cell lung cancer (2022); Interim analysis of phase 3 pivotal INNOVATE-3 trial in recurrent ovarian cancer (2022); Final data from phase 3 pivotal PANOVA-3 trial in locally advanced pancreatic cancer (2022); Final data from phase 3 pivotal INNOVATE-3 trial in recurrent ovarian cancer (2024)"Rubraca (rucaparib) / ClovisRubraca: Patent protection in EU with supplementary protection certificate until 2033 (Clovis Oncology) - Feb 27, 2020 - Annual Report 2019: Patent term extension in US related to composition of matter until Q4 2023; Expiry of patents in 2035; Regulatory exclusivity in EU until 2028- 2029Rubraca (rucaparib) / Clovis; lucitanib (E 3810) / Clovis, HaiHe Pharma, ServierClovis Oncology announces 2019 operating results (Clovis Oncology Press Release) - Feb 24, 2020 - "Rubraca® (rucaparib) net product revenue totaled $143.0M for 2019 and $39.3M for Q4 2019; Net product revenue for 2019 up 50% over 2018; Lucitanib combination studies enrolling; initial data anticipated at medical meetings in 2020; Acquired rights to FAP-2286, a radiopharmaceutical therapy targeting FAP; plan to submit an IND in 2H 2020."Keytruda (pembrolizumab) / Merck (MSD); FPA150 / Five PrimeFive Prime Therapeutics reports fourth quarter and full year 2019 results (Five Prime Therap Press Release) - Feb 27, 2020 - “2020 Milestones and Review of 2019 Business Highlights: Bemarituzumab is being evaluated in combination with mFOLFOX6 in the Phase 3 FIGHT (FGFR2b Inhibition in Gastric and Gastroesophageal Junction Cancer Treatment) trial. The company has paused enrollment in the FIGHT trial pending the occurrence of a sufficient number of events to trigger a futility analysis that is expected to occur in mid-2020; The company remains on track to generate data by mid-2020 from the Phase 1 combination of FPA150 plus pembrolizumab in a cohort of ovarian cancer patients with B7-H4 overexpression; FPT155 - The company remains on track to generate early monotherapy efficacy data in 2020.”Lynparza (olaparib) / Merck (MSD), AstraZenecaLynparza: Patent expiry in US in 2028 (Merck (MSD)) - Feb 29, 2020 - Annual report 2019: Patent expiry in China/EU in 2024 and SPC in EU until 2029; Patent expiry in Japan between 2028 -2029 [Screenshot]
