Bayer to withdraw lymphoma treatment Aliqopa from U.S. market
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Bayer will work with the FDA toward voluntary withdrawal of its follicular lymphoma treatment copanlisib from the U.S. market, according to a company-issued press release.
The pharmaceutical manufacturer’s decision came after an analysis of a phase 3 confirmatory trial showed the agent failed to meet the study’s primary endpoint of improving PFS compared with standard immunochemotherapy among individuals with relapsed follicular lymphoma.
The FDA granted accelerated approval in September 2017 to copanlisib (Aliqopa, Bayer) — a kinase inhibitor — for treatment of adults with relapsed follicular lymphoma who have received at least two prior systemic therapies.
As Healio reported at the time, the agency based approval on results of the phase 2 CHRONOS-1 trial that included 104 patients with follicular B-cell non-Hodgkin’s lymphoma who relapsed after two or more previous treatments.
The FDA required confirmatory trials to sustain the accelerated approval for copanlisib.
The randomized phase 3 CHRONOS-4 trial evaluated the safety and efficacy of copanlisib added to standard immunochemotherapy regimens compared with standard immunochemotherapy alone in patients with relapsed follicular lymphoma.
The trial failed to achieve its primary endpoint of improved PFS vs. standard immunochemotherapy alone.
Bayer plans to publish results from the CHRONOS-4 trial “in a timely manner,” according to the release.
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