Aliqopa was granted accelerated approval in September 2017 to treat adult patients with relapsed follicular lymphoma.
Bayer is withdrawing the cancer drug Aliqopa (copanlisib) from the U.S. market. The FDA granted accelerated approval to Aliqopa in September 2017 to treat adult patients with relapsed follicular lymphoma (FL) who have received at least two prior systemic therapies.
The accelerated approval was based on CHRONOS-1, a single-arm phase a study. The confirmatory trial, CHRONOS-4 study, did not meet its primary endpoint of progression-free survival benefit versus the standard immunochemotherapy control arm in patients with relapsed follicular lymphoma. A spokesperson said no patients in the CHRONOS-4 study are now receiving treatment.
Bayer intends to publish the results of CHRONOS-4.
In a press release, Bayer said it is exploring access options for patients currently receiving Aliqopa who have experienced a favorable response to treatment.
Follicular lymphoma is a slow-growing subtype B-cell non-Hodgkin lymphoma. Although many patients are responsive to initial treatment, about 20% are expected to relapse within two years. Copanlisib is an intravenous PI3K inhibitor. The delta isoform of PI3K is expressed by leukocytes and is involved in B-cell signaling, development, and survival.