Top-line Phase III results for Talzenna/Xtandi showed improved PFS in mCRPC patients regardless of HRR mutation status, where AstraZeneca/Merck have developed fellow PARP inhibitor Lynparza.

Biotech CEOs often express surprise when the FDA rejects their drugs. But collaborative interactions between regulators and drug sponsors count for little if the latter fail to adjust their clinical and regulatory efforts accordingly.

PARP inhibitors appear to be getting the same kind of scrutiny that US FDA has given to P13K inhibitors. AstraZeneca’s Lynparza, GSK’s Zejula, and Clovis’ Rubraca have indications voluntarily withdrawn after ‘potential detrimental effect’ on overall survival seen in randomized clinical trials.

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker