The U.S. Food and Drug Administration has granted priority review status to Bayer‘s new drug application of copanlisib for the treatment of refractory or relapsed follicular lymphoma patients who have received at least two prior therapies.
This designation, granted to medicines that may provide significant improvement in the treatment, diagnosis, or prevention of serious conditions compared to standard therapies, is meant to accelerate the review time from 10 months to six months.
“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,” Carsten Brunn, head of Bayer Pharmaceuticals, Americas Region, said in a press release. “We look forward to continuing to work with the FDA throughout the review process.”
The PI3K pathway is one of the two most frequently activated pathways in cancer. It has been shown to play key roles in cell survival, proliferation, and differentiation. Copanlisib is a reversible PI3K inhibitor with preferential activity against the alpha and beta isoforms.
The FDA’s decision was based on data from the CHRONOS-1 Phase 2 trial (NCT01660451). This open-label, single-arm study was designed to assess the safety and efficacy of copanlisib in patients with relapsed or refractory indolent non-Hodgkin’s lymphoma (iNHL), including follicular lymphoma, who progressed after at least two prior therapies.
The study enrolled 142 patients, 141 of which had iNHL, who received copanlisib on days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
CHRONOS-1 primary endpoint was objective tumor response rate, and secondary endpoints included duration of response, progression-free survival, overall survival, quality of life, and safety.
Data presented at the American Association for Cancer Research (AACR) 2017 Annual Meeting in April revealed that 59% of patients responded to copanlisib, including 12% complete responses. The median duration of response was 98 weeks, or almost two years.
Now, Bayer will be presenting data from the follicular lymphoma subset of the CHRONOS-1 trial at the American Society of Clinical Oncology (ASCO) 2017 Annual Meeting, June 2-6 in Chicago.
The FDA already had granted copanlisib Fast Track and Orphan Drug designation for the treatment of follicular lymphoma patients.
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