14.09.17: Not intended for U.S. and UK Media

Bayer receives FDA approval for Copanlisib in adults with relapsed follicular lymphoma after two prior systemic therapiesAccelerated approval based on overall response rate (ORR) of 104 adult patients with relapsed follicular lymphoma (FL) from the Phase II CHRONOS-1 study / Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial / Copanlisib achieved a 59% ORR in patients with relapsed FL [n=104 (95%CI 49,68)] / First approval of an intravenous phosphatidylinositol-3-kinase (PI3K) inhibitormehr ...
Source: Bayer IR Newsfeed: Events - Category: Pharmaceuticals Source Type: news