FDA Grants Lunsumio Priority Review for Relapsed/Refractory Follicular Lymphoma

The priority review comes following positive clinical trial results, which may lead to a shift in the treatment paradigm for follicular lymphoma, according to an expert.

The Food and Drug Administration (FDA) has granted priority review to Lunsumio (mosunetuzumab) for the treatment of adults with relapsed/refractory follicular lymphoma who have received at least two prior systemic therapies.

Follicular lymphoma often returns after the first line of treatment, and more treatment options are needed after relapse, according to Dr. Levi Garraway, Roche’s Chief Medical Officer and Head of Global Product development.

“New therapeutic options are needed for follicular lymphoma, which often relapses after initial therapy and becomes increasingly difficult to treat each time it returns,” Garraway said in a press release. “Clinical trial results have demonstrated durable responses with Lunsumio in advanced follicular lymphoma, representing a step toward shifting the treatment paradigm.”

These results, which the priority review is based on, are from the phase 2/3 GO29781 study of Lumsumio, which demonstrated high complete response rates (or the disappearance of cancer as a response to treatment), with 57% of patients maintaining a response for at least 18 months with manageable toxicity.

At the median follow up of 18.3 months, the complete response rate was 60% and objective response rate (or the rate of a measurable response to the treatment) was 80%. And the median duration of response (the time the disease responds to a treatment without growth or spread) was 22.8 months.

The most common side effect was cytokine release syndrome, occurring in 39% of patients, but was of low grade and all events were resolved. Other side effects included fatigue, headache, neutropenia, fever and hypophosphatasemia (abnormally low alkaline phosphatase content in circulating blood).

The FDA plans to make the decision on whether to approve the immunotherapy for this population by Dec. 29, 2022.

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