FDA grants priority review to mosunetuzumab for people with relapsed or refractory follicular lymphoma.
Genentech, a member of the Roche Group announced that the FDA has accepted the company’s Biologics License Application (BLA) and granted Priority Review for mosunetuzumab, a potential first-in-class CD20xCD3 T-cell engaging bispecific antibody, for the treatment of adults with relapsed or refractory (R/R) follicular lymphoma (FL) who have received at least two prior systemic therapies.
FL is the most common indolent (slow growing) form of non-Hodgkin’s lymphoma (NHL), a type of blood cancer, which often returns after initial therapy. The FDA is expected to make a decision on approval of this novel cancer immunotherapy by December 29, 2022.
The BLA is based on positive results from the pivotal Phase I/II GO29781 study of mosunetuzumab, which showed high complete response (CR) rates, with the majority of responders (57% [95% CI: 49-70]) maintaining responses for at least 18 months, and manageable tolerability in people with heavily pretreated FL. After a median follow-up of 18.3 months, the CR rate was 60% (n = 54/90) and the objective response rate was 80% (n = 72/90). The median duration of response among those who responded was 22.8 months (95% CI: 9.7-not estimable).
“New therapeutic options are needed for follicular lymphoma, which often relapses after initial therapy and becomes increasingly difficult to treat each time it returns. Clinical trial results have demonstrated durable responses with mosunetuzumab in advanced follicular lymphoma, representing a step toward shifting the treatment paradigm,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “Since 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.”
A robust development program for mosunetuzumab is ongoing including two Phase III studies: CELESTIMO investigating mosunetuzumab plus lenalidomide in second-line plus (2L+) FL, and SUNMO, investigating mosunetuzumab plus Polivy (polatuzumab vedotin) in 2L+ diffuse large B-cell lymphoma (DLBCL).
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