FDA Sets Review Date for Linvoseltamab for Advanced Multiple Myeloma

The FDA has accepted for priority review the biologics license application (BLA) for linvoseltamab to treat adult patients with relapsed/refractory multiple myeloma that has progressed after at least three prior therapies. The FDA’s target action date is Aug. 22, 2024.

Multiple myeloma is an aggressive and incurable blood cancer that affects plasma cells made in the bone marrow. More than 35,000 new cases of multiple myeloma are diagnosed annually in the United States. While current treatments are able to slow the progression of the cancer, most patients will ultimately experience disease progression and require additional therapies

L. Andres Sirulnik, M.D., Ph.D.

“Multiple myeloma remains an incurable disease, in which patients endure cycles of relapse and remission, resulting in a critical need for innovative medicines,” L. Andres Sirulnik, M.D., Ph.D., senior vice president, Translational and Clinical Sciences, Hematology at Regeneron Pharmaceuticals, said in a press release.

Developed by Regeneron, linvoseltamab is a bispecific antibody designed to bridge B-cell maturation antigen on multiple myeloma cells with CD3-expressing T cells.

The BLA is supported by data from a phase 1/2 trial. Results from this trial were released in December 2023. At a median duration of follow-up of 11 months where 117 patients received linvoseltamab 200 mg, the objective response rate was 71%, with 46% achieving a complete response or better.

All patients treated with 200 mg experienced an adverse event, including 85% who experienced Grade ≥3 adverse events. The most commonly occurring adverse events was cytokine release syndrome; most (35%) were Grade 1. Adjudicated immune effector cell-associated neurotoxicity syndrome (ICANS) events — which are neurotoxicities that can happen in patients receiving CAR T therapies — occurred in 9 patients. Deaths due to treatment-emergent adverse events on-treatment or within 30 days post last dose occurred in 14 patients, of which 11 were due to infections.

A phase 3 confirmatory trial in patients with relapsed/refractory multiple myeloma is currently enrolling.

Additional trials in earlier lines of therapy and stages of disease are planned or under way, including a phase 1/2 trial in the first-line setting, a phase 2 trial in high-risk smoldering multiple myeloma and a phase 2 trial in monoclonal gammopathy of undetermined significance. A phase 1 trial of linvoseltamab in combination with a regeneron CD38xCD28 costimulatory bispecific in multiple myeloma is also planned.