publication date: Sep. 15, 2017

Drugs and Targets Bayer’s Aliqopa gets FDA accelerated approval for relapsed follicular lymphoma

FDA granted accelerated approval to Aliqopa (copanlisib) for the treatment of adults with relapsed follicular lymphoma who have received at least two prior systemic therapies.

Aliqopa, a kinase inhibitor that works by blocking several enzymes that promote cell growth, is sponsored by Bayer Healthcare Pharmaceuticals Inc.

Further clinical trials are required to confirm Aliqopa’s clinical benefit and the sponsor is currently conducting these studies.

The approval of Aliqopa 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 percent of patients had a complete or partial response for a median 12.2 months.

“For patients with relapsed follicular lymphoma, the cancer often comes back even after multiple treatments,” said Richard Pazdur, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the 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.”

Common side effects of Aliqopa include high blood sugar levels (hyperglycemia), diarrhea, decreased general strength and energy, … Continue reading Bayer’s Aliqopa gets FDA accelerated approval for relapsed follicular lymphoma

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