Posted by Michael Wonder on 18 May 2017
Bayer receives FDA priority review for investigational anti-cancer compound copanlisib
17 May 2017 - Regulatory submission based on data from the Phase II CHRONOS-1 study, in which copanlisib showed objective response rate of 59% and a manageable safety profile in patients with follicular lymphoma.
Bayer today announced that the U.S. FDA has granted priority review designation for the New Drug Application for copanlisib for the treatment of relapsed or refractory follicular lymphoma patients who have received at least two prior therapies. Copanlisib is an intravenous pan-class I phosphatidylinositol-3-kinase inhibitor with predominant inhibitory activity against PI3K-α and PI3K-δ isoforms. Follicular is the most common subtype of indolent non-Hodgkin’s lymphoma.
