Positive initial data from a pivotal phase II expansion cohort evaluating investigational linvoseltamab (BCMAXCD3, formerly REGN5458) at the 200 mg dose recommended for further development in patients with heavily pre-treated, relapsed/refractory multiple myeloma, were presented at the 64th American Society of Hematology Annual Meeting and Exposition.
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.
