Bayer receives FDA approval for Copanlisib in adults with relapsed follicular lymphoma after two prior systemic therapies (for specialized target groups only)

Accelerated 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) inhibitor
Source: Bayer Company News - Category: Pharmaceuticals Source Type: news