FDA Grants Priority Review to Copanlisib for Follicular Lymphoma

May 17, 2017 – The FDA has granted a priority review designation to copanlisib as a treatment for patients with relapsed/refractory follicular lymphoma who have received at 2 least prior therapies, according to Bayer, the manufacturer of the PI3K dual-isoform inhibitor. The new drug application (NDA) for copanlisib is based primarily on findings from the the phase II CHRONOS-1 trial, which included patients with multiple types of lymphoma. In the study, 59% … (leggi tutto)