www.fdanews.com/articles/183570-bayers-aliqopa-wins-accelerated-approval
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Bayer’s Aliqopa Wins Accelerated Approval
September 19, 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.