Accelerated Approval was granted to Bayer Healthcare Pharmaceuticals’ Aliqopa (copanlisib) today for the treatment of follicular lymphoma.
The full indication for the approval is for adults with relapsed follicular lymphoma who have received at least 2 previous systemic therapy treatments. The drug had previously received both Priority Review and Orphan Drug designations from the FDA.
Follicular lymphoma is the most common indolent type of non-Hodgkin lymphoma, progresses slowly, and is characterized by cycles of remission and relapse. It develops from B lymphocytes, or B cells, and frequent symptoms include the enlargement of lymph nodes in the neck, underarms, abdomen, or groin. Symptoms, however, can also include flu-like symptoms like night sweats.
Per the Virginia Cancer Institute, approximately 14-15,000 new cases of follicular cancer are diagnosed each year.
“For patients with relapsed follicular lymphoma, the cancer often comes back even after multiple treatments,” said Richard Pazdur, M.D., 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 in the official FDA press release
. “Options are limited for these patients and today’s approval provides an additional choice for treatment, filling an unmet need for them.”
The Accelerated Approval enables the FDA to approve drugs for severe conditions to fill an unmet medical need using clinical trial data that is expected to provide a clinical benefit to patients. Further clinical trials are still necessary to confirm Aliqopa’s safety and efficacy.
In a single-arm trial that evaluated Aliqopa in 104 patients with follicular B-cell non-Hodgkin lymphoma who had relapsed disease following at least 2 previous treatments, 59% of patients had a complete or partial response for a median 12.2 months.
Adverse events (AEs) of Aliqopa throughout the study included hyperglycemia, diarrhea, fatigue, hypertension, nausea, tract infections, and thrombocytopenia, in addition to low levels of certain white blood cells (leukopenia and neutropenia).
Inflammation of the lung tissue and severe skin reactions are also risks, and women who are pregnant or breastfeeding should not take Aliqopa because of the potential harm it could cause to a developing fetus or newborn baby.
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