Posted: Wednesday, July 6, 2022
Genentech, a member of the Roche Group, recently announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s biologics license application and granted Priority Review for mosunetuzumab (Lunsumio). This potential first-in-class CD20 x CD3 T-cell–engaging bispecific antibody is being evaluated in the treatment of adults with relapsed or refractory follicular lymphoma or follicular lymphoma who have received at least two prior systemic therapies. The FDA is expected to decide on approval of this immunotherapy by December 29, 2022.
The application is based on results from the phase I/II multicenter, open-label, dose-escalation and -expansion GO29781 study. In this trial, mosunetuzumab induced high complete response rates in people with heavily pretreated follicular lymphoma. In addition, 57% (95% confidence interval = 49%–70%) were reported to be maintaining responses for at least 18 months. The most common adverse event was cytokine-release syndrome (39%), which was generally low grade, and all events resolved. Other common adverse events (> 20%) included fatigue, headache, neutropenia, fever, and hypophosphatemia.
In June 2022, the European Commission granted conditional marketing authorization for mosunetuzumab in the treatment of people with relapsed or refractory follicular lymphoma who have received at least two prior systemic therapies.