FDA Approves Copanlisib for Relapsed Follicular Lymphoma


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THE U.S. FOOD AND DRUG ADMINISTRATION (FDA) has granted accelerated approval to copanlisib (Aliqopa) for the treatment of adults with relapsed follicular lymphoma who have received at least two prior systemic therapies. 

Copanlisib is a kinase inhibitor that works by blocking several enzymes that promote cell growth. Further clinical trials are required to confirm copanlisib’s clinical benefits. 

Approval of copanlisib was based on data from the CHRONOS-1 trial, a single-arm study that included 104 patients with follicular B-cell non-Hodgkin lymphoma who had relapsed disease after at least two prior treatments. In the trial, 59% of patients had a complete or partial response for a median 12 months. 

Common side effects of copanlisib include hyperglycemia, diarrhea, and decreased general strength and energy. For more information visit FDA.gov. ■



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