Priority Review for Bayer's PI3K in follicular lymphoma

FDA accepted and granted Priority Review to an NDA from Bayer AG (Xetra:BAYN) for copanlisib (BAY 80-6946) as a third-line therapy to treat relapsed or refractory follicular lymphoma. Bayer did not respond to an inquiry about the candidate's PDUFA date, but said it expects a decision within six months.

The NDA includes data from the Phase II CHRONOS-1 trial, in which copanlisib led to an overall response rate (ORR) of 58.7% and a median PFS of 11.2 months among 104 patients with follicular lymphoma...