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FDA approves Aliqopa for follicular lymphoma
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The FDA today granted accelerated approval to copanlisib for the treatment of adults with relapsed follicular lymphoma.
The approval applies to patients who received at least two previous systemic therapies.
“For patients with relapsed follicular lymphoma, the cancer often comes back even after multiple treatments,” Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, said in a press release. “Options are limited for these patients, and today’s approval provides an additional choice for treatment, filling an unmet need for them.”
Copanlisib (Aliqopa, Bayer HealthCare), a kinase inhibitor, blocks several enzymes that promote cell growth.
The FDA based the approval on results of a single-arm trial that included 104 patients with follicular B-cell non-Hodgkin’s lymphoma who relapsed after two or more previous treatments.
More than half (59%) of patients in the trial achieved complete or partial response to copanlisib. Researchers reported median duration of response of 12.2 months.
Common side effects associated with copanlisib treatment include hyperglycemia, diarrhea, decreased general strength and energy, hypertension, leukopenia, neutropenia, nausea, lower respiratory tract infections and thrombocytopenia.
Serious side effects include infections, hyperglycemia, hypertension, noninfectious pneumonitis, neutropenia and severe skin reactions.
Because the FDA granted accelerated approval, additional clinical trials are required to confirm copanlisib’s clinical benefit. Bayer HealthCare is conducting these studies.
The FDA previously granted priority review and orphan drug designation to copanlisib.