FDA approves Aliqopa (copanlisib) to treat patients with relapsed follicular lymphoma.- Bayer HealthCare.

Bayer announced that the FDA has approved copanlisib under the brand name Aliqopa 60 mg vial for injection for the treatment of adult patients with relapsed follicular lymphoma who have received at least two prior systemic therapies. Accelerated approval was granted for this indication based on overall response rate (ORR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Copanlisib is a novel intravenous phosphatidylinositol-3-kinase (PI3K) inhibitor with inhibitory activity predominantly against the PI3K-alpha and PI3K-delta isoforms expressed in malignant B cells. The FDA granted approval under the accelerated approval pathway based on data from the open-label, single-arm Phase II CHRONOS-1 [NCT01660451] trial investigating copanlisib in 104 adult patients with follicular B-cell non-Hodgkin’s lymphoma (NHL) who had relapsed disease following at least two prior systemic therapies. Follicular lymphoma (FL) is the most common subtype of indolent, or slow-growing, non-Hodgkin’s lymphoma (NHL). Response rates and duration of response decline with each line of therapy, underscoring the need for patients whose disease has already progressed.

Developed by Bayer, copanlisib is the only approved PI3K inhibitor with inhibitory activity predominantly against PI3K-alpha and PI3K-delta isoforms expressed in malignant B cells. It is also the only one to be administered intravenously on an intermittent schedule. Copanlisib will be available in the U.S. market immediately.