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First-Line Ovarian Cancer Approval Solidifies Lead For AstraZeneca's Lynparza

 
• By Emily Hayes

Lynparza will be the first PARP inhibitor cleared for maintenance treatment to extend response to first-line chemo, but in BRCA mutant patients – while Tesaro/GSK should have Phase III results for Zejula monotherapy in all-comers in 2019.  

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AstraZeneca PLC/Merck & Co. Inc.'s Lynparza is breaking new ground in ovarian cancer with the first approval of a PARP inhibitor as first-line maintenance therapy in BRCA-mutated ovarian cancer.

After a speedy review, the US FDA approved Lynparza (olaparib) Dec. 19 as a monotherapy in BRCA+ patients in partial or complete response to first-line platinum-based chemotherapy. The companies had announced acceptance of the filing on Nov. 12, with expectations of approval in the first quarter of 2019; the application had priority review

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