The FDA has granted accelerated approval to copanlisib (Aliqopa, Bayer Healthcare Pharmaceuticals) 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.”
Follicular lymphoma is a slow-growing type of non-Hodgkin lymphoma, a cancer of the lymph system (a part of the body’s immune system made up of lymph tissue, lymph nodes, the spleen, thymus, tonsils, and bone marrow). The National Cancer Institute estimates that approximately 72,240 people in the United States will be diagnosed with some form of non-Hodgkin lymphoma this year; approximately 20,140 patients with non-Hodgkin lymphoma will die from the disease in 2017.
Copanlisib is a kinase inhibitor that works by blocking several enzymes that promote cell growth. It received accelerated approval. Further clinical trials are required to confirm copanlisib’s clinical benefit, and Bayer is conducting these studies.
The approval of copanlisib was based on data from a single-arm trial that included 104 patients with follicular B-cell non-Hodgkin lymphoma who had relapsed disease following at least two prior treatments. The trial measured how many patients experienced complete or partial shrinkage of their tumors after treatment (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 and orphan drug designations.
Source: FDA; September 14, 2017