BioCentury
ARTICLE | Clinical News

FDA approves Bayer’s PI3K inhibitor for follicular lymphoma

September 15, 2017 9:10 PM UTC

FDA granted accelerated approval to an NDA from Bayer AG (Xetra:BAYN) for Aliqopa copanlisib (BAY 80-6946) as a third-line therapy to treat relapsed or refractory follicular lymphoma. Bayer told BioCentury Aliqopa will be available immediately in the U.S. at a monthly wholesale acquisition cost (WAC) of $12,600.

The approval was based on data from the single-arm Phase II CHRONOS-1 trial, in which Aliqopa led to an overall response rate (ORR) of 58.7% and a median progression-free survival (PFS) of 11.2 months among 104 patients with follicular lymphoma. ...

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