AstraZeneca and Merck & Co. said Tuesday that European regulators approved Lynparza (olaparib) for use as a maintenance therapy for patients with platinum-sensitive relapsed high-grade, epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete response or partial response to platinum-based chemotherapy, regardless of BRCA status. AstraZeneca added that Health Canada also cleared the PARP inhibitor for the same indication.
Dave Fredrickson, head of AstraZeneca's oncology business unit, remarked "with this new approval for Lynparza, we will now be able to offer more women with platinum-sensitive ovarian cancer, regardless of their BRCA status, a chance to achieve long-term disease control with an oral medicine that has a well-characterised safety and tolerability profile."
The expanded approval of the drug, which followed a positive recommendation from the European Medicines Agency's Committee for Medicinal Products for Human Use in February, was supported by data from the SOLO-2 and Study 19 studies. Data from the SOLO-2 trial demonstrated that Lynparza significantly prolonged progression-free survival versus placebo. Meanwhile, results from Study 19 indicated that the treatment may improve overall survival as maintenance therapy following platinum-based chemotherapy.
FirstWord reports in this therapy area - KOL Insight Ovarian Cancer: Find out how KOLs expect the market to evolve, which pipeline treatments are most promising, and which clinical trials will shape treatment decisions. Learn more.
Lynparza was initially authorised in Europe as a capsule formulation for women with BRCA-mutated platinum-sensitive relapsed ovarian cancer, while a filing has also been submitted for patients with BRCA-mutated, HER2-negative metastatic breast cancer, with the EMA accepting the application last month. The companies noted that a new tablet formulation of the drug inhibitor reduces dosing from eight capsules twice daily to two tablets twice daily.
AstraZeneca and Merck inked a deal last July potentially worth as much as $8.5 billion to co-develop Lynparza for multiple cancer indications, including breast, pancreatic and prostate cancers.
To read more Top Story articles, click here.