14 November 2023 - Bayer today announced that, following discussions with the US FDA, it will work with the FDA on a voluntary withdrawal of the Aliqopa (copanlisib) US new drug application for adult patients with relapsed follicular lymphoma who have received at least two prior systemic therapies.

Aliqopa was granted accelerated approval by the FDA in September 2017 based on CHRONOS-1, an open-label, single-arm, Phase 2 study. The FDA required clinical benefit to be confirmed through the CHRONOS-4 study. In the study, the addition of Aliqopa to standard immunochemotherapy regimens did not meet the primary outcome of progression-free survival benefit versus the standard immunochemotherapy control arm in patients with relapsed follicular lymphoma.

Read Bayer press release