On September 14, 2017, the FDA granted accelerated approval to copanlisib (Aliqopa; Bayer Healthcare) for the treatment of adults with relapsed follicular lymphoma who have received ≥2 previous systemic therapies. Copanlisib received priority review and an orphan drug designation for this indication.
“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. “Options are limited for these patients and today’s approval provides an additional choice for treatment, filling an unmet need for them,” he added.
The approval of copanlisib for patients with relapsed follicular lymphoma was based on the single-arm, multicenter, phase 2 clinical trial CHRONOS-1 involving 104 patients with follicular B-cell non-Hodgkin lymphoma that relapsed after ≥2 previous therapies. The primary efficacy end point was overall response rate (ORR). The ORR was 59% (95% confidence interval, 49%-68%), the median duration of response was 12.2 months, and the median time to response was 1.7 months (range, 1.3-9.7 months).
The most common (≥20%) adverse reactions reported with copanlisib therapy include hyperglycemia, diarrhea, decreased general strength and energy, hypertension, leukopenia, neutropenia, nausea, lower respiratory tract infections, and thrombocytopenia.
