FDA Grants Priority Review To Genentech's Mosunetuzumab For Refractory Follicular Lymphoma

Genentech, a member of the Roche Group (RHHBY), said Wednesday that the U.S. Food and Drug Administration has accepted the company's Biologics License Application or 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 or FL who have received at least two prior systemic therapies.

The application is based on results from the pivotal Phase I/II study showing mosunetuzumab induced high and durable complete response rates in people with follicular lymphoma who received two or more prior therapies.

Mosunetuzumab could be the first CD20xCD3 T-cell engaging bispecific antibody approved by the FDA for the treatment of any type of non-Hodgkin's lymphoma.

Follicular lymphoma 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 European Commission granted conditional marketing authorization for mosunetuzumab for the treatment of people with R/R FL who have received at least two prior systemic therapies in June 2022.

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