FDA grants priority review to mosunetuzumab for relapsed or refractory follicular lymphoma
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The FDA granted priority review to mosunetuzumab for treatment of certain patients with relapsed or refractory follicular lymphoma.
The designation applies to use of the agent by adults who received at least two prior systemic therapies.
Mosunetuzumab (Genentech) is a bispecific CD20/CD3 antibody.
A biologics license application is based on results of the open-label phase 1/phase 2 GO29781 study, which included 90 patients with follicular lymphoma who had received two or more prior therapies.
Complete response rate per independent revie served as the primary endpoint. Secondary endpoints included objective response rate, duration of response, PFS, safety and tolerability.
Healio previously reported study results presented during last year’s ASH Annual Meeting and Exposition.
After median follow-up of 18.3 months, researchers reported an 80% ORR and 60% complete response rate. Median duration of response was 22.8 months (95% CI, 9.7-not estimable), and more than half (57%) of responders maintained their responses for at least 18 months.
The most common adverse event was cytokine release syndrome (39%), with the majority of cases being low grade (grade 1, 25.6%; grade 2, 14%; grade 3, 2.3%; grade 4, 0.5%). All events resolved.
Other common adverse events that occurred among more than 20% of study participants included fatigue, headache, neutropenia, fever and hypophosphatemia.
The FDA is expected to make a decision on approval by Dec. 29.
“New therapeutic options are needed for follicular lymphoma, which often relapses after initial therapy and becomes increasingly difficult to treat each time it returns,” Levi Garraway, MD, PhD, chief medical officer and head of global product development for Genentech, said in a company-issued press release. “Clinical trial results have demonstrated durable responses with mosunetuzumab in advanced follicular lymphoma, representing a step toward shifting the treatment paradigm. [Because] mosunetuzumab does not require the collection or genetic modification of patient cells, it could become an effective, fixed-duration outpatient option without the barriers of travelling to a major academic center.”
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