Bayer AG, a great german company, page-11

Bayer Receives FDA Priority Review For Investigational Anti-Cancer Compound Copanlisib

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 (FL) / Copanlisib is an intravenous pan-class I phosphatidylinositol-3-kinase (PI3K) inhibitor with predominant activity against PI3K-α and PI3K-δ isoforms / Copanlisib granted Fast Track and Orphan Drug Designation in the U.S. for FL
Berlin, May 17, 2017 - Bayer today announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review designation for the New Drug Application (NDA) for copanlisib for the treatment of relapsed or refractory follicular lymphoma (FL) patients who have received at least two prior therapies. Copanlisib is an intravenous pan-class I phosphatidylinositol-3-kinase (PI3K) inhibitor with predominant inhibitory activity against PI3K-α and PI3K-δ isoforms. FL is the most common subtype of indolent non-Hodgkin's lymphoma (iNHL).

"Patients with relapsed or refractory follicular lymphoma have a poor prognosis, and new treatment options which are well tolerated and effective are needed to prolong progression-free survival and improve quality of life for these patients," said Martin Dreyling, Professor of Medicine at the University of Munich Hospital in Grosshadern and lead investigator of the CHRONOS-1 study. "Based on the CHRONOS-1 results, where copanlisib showed durable efficacy with a manageable and distinct safety profile, the compound may have the potential to address this unmet medical need."

"Bayer is advancing one of the most diverse oncology portfolios and pipelines and our first priority is to deliver new treatments to cancer patients as quickly and prudently as possible," said Robert LaCaze, Executive Vice President and Head of the Oncology Strategic Business Unit at Bayer. "With this milestone, we are one step closer to making copanlisib available in the U.S. to the community of doctors and patients facing a very difficult-to-treat disease in follicular lymphoma. We look forward to continuing to work with the FDA throughout the review process."

The FDA grants Priority Review for the applications of medicines that, if approved, would provide significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions, when compared to standard applications. Under the Prescription Drug User Fee Act (PDUFA), the FDA aims to complete its review within six months (compared to 10 months under standard review).