FDA accepted the Biologics License Application 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 follicular lymphoma who have received at least two prior systemic therapies.
In a unanimous vote, the FDA Oncologic Drugs Advisory Committee advised the agency to accept the metric of “minimal residual disease,” or MRD, as a basis for accelerated approvals of therapies in all settings of multiple myeloma.
