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FDAnews Drug Daily Bulletin

Bayer’s Aliqopa Wins Accelerated Approval

Sept. 20, 2017

The FDA also granted accelerated approval to Bayer Healthcare’s Aliqopa (copanlisib) for relapsed follicular lymphoma, a type of non-Hodgkin lymphoma. Aliqopa works by blocking several enzymes that promote cell growth.

The approval was based on a single-arm trial of 104 patients who had relapsed disease following at least two prior treatments.

Fifty-nine percent of patients had a complete or partial response for a median 12.2 months.

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