AZ's Lynparza PARP Lead Likely To Lengthen With FDA Priority Review
Despite suffering a setback at the hands of NICE, AstraZeneca's ambitious plans for Lynparza have been boosted by the FDA agreeing to speed up a review of the recent SOLO-1 data which took ESMO by storm last month.
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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.
Combination studies of drugs for ovarian cancer have heavy focus on PARP, PD-1/L1 and VEGF mechanisms.
AstraZeneca's Lynparza, Tesaro's Zejula and Clovis' Rubraca have brought much needed advances to patients with ovarian cancer, but the market is relatively small and the competition intense, while unmet need remains high.