FDA Grants Accelerated Approval to Lynozyfic for Advanced Multiple Myeloma

FDA Grants Accelerated Approval to Lynozyfic for Advanced Multiple Myeloma

Regeneron Pharmaceuticals has announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Lynozyfic™ (linvoseltamab-gcpt) to treat adults with relapsed or refractory multiple myeloma (R/R MM) who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

Lynozyfic is a bispecific antibody that targets B-cell maturation antigen (BCMA) on myeloma cells and CD3 on T cells, facilitating T-cell activation and cancer cell killing. It is the first FDA-approved BCMAxCD3 bispecific antibody with a response-adapted dosing regimen, allowing for dosing every two weeks starting at week 14, and every four weeks if a very good partial response or better is achieved after 24 weeks of therapy. 

The approval is based on results from the Phase 1/2 LINKER-MM1 trial, where 70% of patients achieved an objective response, and 45% achieved a complete response or better. The median time to first response was 0.95 months, and the median duration of response was not reached, with an estimated 72% of responders maintaining their response at 12 months. 

Lynozyfic carries a Boxed Warning for cytokine release syndrome and neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome. The most common adverse reactions (≥20%) included musculoskeletal pain, cytokine release syndrome, cough, upper respiratory tract infection, diarrhea, fatigue, pneumonia, nausea, headache, and dyspnea. Lynozyfic is available only through a restricted program called the Lynozyfic Risk Evaluation and Mitigation Strategy (REMS).

This approval provides a new treatment option for patients with heavily pre-treated multiple myeloma, addressing a significant unmet medical need in this population.