US regulators have issued an accelerated approval for Bayer’s relapsed follicular lymphoma therapy Aliqopa.
The decision allows physicians in the country to prescribe the drug to patients who have received at least two prior systemic therapies.
Follicular lymphoma is a slow-growing type of non-Hodgkin lymphoma, a cancer of the lymph system, and despite being the most common form of NHL is considered a rare disease with unmet need.
Aliqopa (copanlisib), a kinase inhibitor that blocks several enzymes that promote cell growth, has been issued speedy clearance on the back of early clinical trial data showing that 59 percent of patients taking the drug had a complete or partial response for a median 12.2 months.
However, further clinical trials are required to confirm its clinical benefit if the accelerated approval is to be converted into a full one, which Bayer is currently running.
“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 agency’s Center for Drug Evaluation and Research.
“Options are limited for these patients and [Aliqopa’s] approval provides an additional choice for treatment, filling an unmet need for them.”