FDA Approves Copanlisib for Adults With Relapsed Follicular Lymphoma

Today, the U.S. Food and Drug Administration (FDA) granted accelerated approval to copanlisib (Aliqopa) for the treatment of adults with relapsed follicular lymphoma who have received at least two prior systemic therapies.

“For patients with relapsed follicular lymphoma, the cancer often comes back even after multiple treatments,” said 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. “Options are limited for these patients, and today’s approval provides an additional choice for treatment, filling an unmet need for them.”

Copanlisib is a kinase inhibitor that works by blocking several enzymes that promote cell growth. It received an Accelerated Approval, which enables the FDA to approve drugs for serious conditions to fill an unmet medical need using clinical trial data that is thought to predict a clinical benefit to patients. Further clinical trials are required to confirm copanlisib’s clinical benefit, and the sponsor is currently conducting these studies.


Today’s 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 following at least two prior treatments. The trial measured overall response rate. In the trial, 59% of patients had a complete or partial response for a median 12.2 months.

Common side effects of copanlisib 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. Women who are pregnant or breastfeeding should not take copanlisib because it may cause harm to a developing fetus or newborn baby.

Copanlisib was granted Priority Review designation, under which the FDA’s goal is to take action on an application within 6 months where the agency determines that the drug, if approved, would significantly improve the safety or effectiveness of treating, diagnosing, or preventing a serious condition. Copanlisib also received Orphan Drug designation, which provides incentives to assist and encourage the development of drugs for rare diseases.

The FDA granted the approval of copanlisib to Bayer Healthcare Pharmaceuticals, Inc.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.




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