Bayer announced that the FDA 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.
"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," said Carsten Brunn, head of Bayer Pharmaceuticals, Americas Region. "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).
The regulatory submission for copanlisib is based on data from the phase II open-label, single-arm CHRONOS-1 study evaluating patients with relapsed or refractory indolent non-Hodgkin's lymphoma (iNHL). The full analysis set comprised 142 patients, of which 141 patients had iNHL. The full data set was presented at the American Association for Cancer Research (AACR) Annual Meeting 2017.
Bayer is 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.
CHRONOS-1 is an open-label, single-arm phase II study (ClinicalTrials.gov Identifier: NCT01660451) evaluating copanlisib as a monotherapy in non-Hodgkin's lymphoma patients. CHRONOS-1 was designed to evaluate the efficacy and safety of copanlisib in patients with relapsed or refractory indolent NHL, including follicular lymphoma (FL), who received at least two prior therapies. The primary endpoint of CHRONOS-1 is the objective tumor response rate, with duration of response, overall survival, progression-free survival, quality of life and safety serving as secondary endpoints.