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FDA grants priority review to copanlisib for follicular lymphoma
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The FDA granted priority review to copanlisib for the treatment of patients with relapsed or refractory follicular lymphoma who received at least two prior therapies, according to the drug’s manufacturer.
Copanlisib (BAY 80-6946, Bayer) is a pan-Class I PI3 kinase inhibitor.
The regulatory submission for copanlisib is based on results from the open-label, single-arm phase 2 CHRONOS-1 study, designed to evaluate the safety and efficacy of copanlisib monotherapy in 141 patients with relapsed or refractory indolent non-Hodgkin lymphoma — including follicular lymphoma — who received at least two prior therapies.
Objective tumor response rate served as the primary endpoint. Secondary endpoints included response duration, OS, PFS, quality of life and safety.
The full data set from CHRONOS-1 was presented at this year’s American Association for Cancer Research Annual Meeting. Data from the follicular lymphoma subset will be presented at the ASCO Annual Meeting in June.
"With this milestone, we are one step closer to making copanlisib available in the United States 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 company-issued press release. “We look forward to continuing to work with the FDA throughout the review process.”
Bayer seeks accelerated approval of copanlisib for treatment of relapsed/refractory follicular lymphoma. The FDA previously granted the agent fast track and orphan drug designations for this indication.