Missing Confirmatory Trial Endpoint Causes Bayer to Withdraws Aliqopa

November 16, 2023

Bayer is issuing a voluntary withdrawal of Aliqopa (copanlisib) after the PI3K inhibitor failed to meet the primary endpoint of progression-free survival in its postmarketing confirmatory trial.

The company came to the decision after talks with the FDA, according to a press statement. Bayer would like to continue to offer the drug on a limited basis to some current patients but emphasized that no new prescriptions should be issued.

The drug, which was indicated for adult patients with relapsed follicular lymphoma who have received at least two prior systemic therapies, won an Accelerated Approval in 2017. That approval was based on one open-label, single-arm phase 2 study. The FDA required confirmatory clinical proof of efficacy in a postmarketing trial.

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