FDA priority review given to Bayer’s investigational blood cancer drug
Bayer announces that its investigational blood cancer treatment, copanlisib, has been awarded priority review designation from the FDA, thereby meaning the regulator pledges to review the product within a six-month timeframe.
The blood cancer drug is an intravenous pan-class I phosphatidylinositol-3-kinase (PI3K) inhibitor with predominant inhibitory activity against PI3K-α and PI3K-δ isoforms. It is indicated in the treatment of follicular lymphoma. A regular subtype of indolent non-Hodgkin’s lymphoma, in cases where the disease has seen resurgence after use of two previous therapies. In Phase 2 trials, the drug proved its promising efficacy, causing cancer to recede in around 60% of patients.
“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,” explained Martin Dreyling, Professor of Medicine at the University of Munich Hospital in Grosshadern and lead investigator of the 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 predicts that the product will reach peak annual sales of €500 million, but analysts believe that the product could go on to exceed expectations and gross as much as €600 million.
Robert LaCaze, Bayer’s Executive Vice President and Head of the Oncology Strategic Business Unit, added: “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. With this milestone, we are one step closer to making copanlisib available in the US 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.”
Source – PharmaFile