The US Food and Drug Administration has granted Bayer Priority Review for its New Drug Application for copanlisib for the treatment of relapsed or refractory follicular lymphoma patients who have received at least two previous therapies.
Copanlisib is an intravenous pan-class I phosphatidylinositol-3-kinase inhibitor with predominant inhibitory activity against PI3K-α and PI3K-δ isoforms.
Follicular lymphoma (FL) is the most common subtype of indolent non-Hodgkin’s lymphoma.
“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.
He added: “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.”
Robert LaCaze, Executive Vice President and Head of the Oncology Strategic Business Unit at Bayer, said: “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.”
Bayer is currently seeking accelerated approval of copanlisib for FL under FDA regulations 21 CFR Part 314 Subpart H.
The compound was also granted Fast Track and Orphan Drug Designation by the FDA in this indication.