July 2, 2025—According to this press release from Regeneron Pharmaceuticals Inc., the "U.S. Food and Drug Administration (FDA) has granted accelerated approval for Lynozyfic™ (linvoseltamab-gcpt) to treat adult patients with relapsed or refractory (R/R) multiple myeloma (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 was granted accelerated approval based on response rate and durability of response in the LINKER-MM1 trial. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial."

Lynozyfic is the first FDA-approved BCMAxCD3 bispecific antibody that can be given every two weeks starting at week 14, and every four weeks if patients show a very good partial response or better after 24 weeks of treatment. The regimen includes two 24-hour hospital stays during the initial step-up dosing phase for safety monitoring.

FDA approval of Lynozyfic is based on the Phase 1/2 LINKER-MM1 trial in relapsed/refractory multiple myeloma, where 70% of patients responded to treatment and 45% achieved a complete response or better. The drug carries a Boxed Warning for cytokine release syndrome and neurologic toxicity, and it is only available through the Lynozyfic REMS program due to its safety risks.

To learn more about this FDA approval, read the full press release from the button below: