New Drug Approved for Relapsed Lymphoma: Copanlisib

Zosia Chustecka

September 14, 2017

Adult patients with follicular lymphoma who have relapsed after trying at least two systemic therapies now have a new option: copanlisib (Aliqopa, Bayer). The drug has just been granted an accelerated approval for use in such patients and also had orphan drug status.

"For patients with relapsed follicular lymphoma, the cancer often comes back even after multiple treatments," said Richard Pazdur, MD, director of the US Food and Drug Administration (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," he said.

Copanlisib is a pan class I phosphatidylinositol-3-kinase (PI3K) inhibitor with predominant inhibitory activity against PI3K-alpha and PI3K-delta isoforms. It is the first of this class to be approved for lymphoma.

The accelerated approval granted by the FDA was based on data from a single-arm trial that included 104 patients with follicular B-cell non-Hodgkin lymphoma who had relapsed after at least two prior treatments. The main endpoint was overall response rate, which was seen in 59% of patients. These patients had a complete or partial response for a median 12.2 months, the agency noted. 

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. The product labeling also warns that women who are pregnant or breastfeeding should not take the drug because of potential for harm to  a developing fetus or newborn baby.

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