FRANKFURT (Reuters) – Bayer on Monday said it would voluntarily withdraw the follicular lymphoma drug Aliqopa, also known as copanlisib, from the U.S. market after a trial designed to confirm its benefit did not show the desired effect on overall survival.
The decision follows discussions with the U.S. Food and Drug Administration, Bayer said in a statement.
Based on a Phase II study, Aliqopa was granted accelerated approval by the FDA in 2017 for adults with follicular lymphoma whose disease had returned after at least two prior systemic therapies, but the go-ahead was contingent on further trials.
In a follow-up study the FDA had required, the addition of Aliqopa to standard immunochemotherapy did not meet the target for progression-free survival when compared to the control group in patients on standard immunochemotherapy, Bayer added.
(Reporting by Ludwig Burger; editing by Matthias Williams)
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Publish date : 2023-11-14 15:37:11
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