Press release
Lynozyfic™ (linvoseltamab-gcpt) Receives FDA Accelerated Approval for Treatment of Relapsed or Refractory Multiple Myeloma
TARRYTOWN, N.Y., July 02, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration
About this update from Regeneron Pharmaceuticals, Inc.
[{"type":"text","content":"TARRYTOWN, N.Y., July 02, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that 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 dosed every two weeks starting at week 14, and every four weeks if a very good partial response (VGPR) or better is achieved following completion of at least 24 weeks of therapy. The regimen includes hospitalization for safety during the step-up dosing period (one 24-hour period after the first step-up dose, and another 24-hour period after the second step-up dose). “The FDA approval of Lynozyfic represents meaningful progress for the multiple myeloma community. Lynozyfic demonstrated early, deep and durable responses in heavily pre-treated patients, which I saw firsthand in clinical trials,” said Sundar Jagannath, M.D., Network Director of the Center of Excellence for Multiple Myeloma at Mount Sinai in New York City and a trial investigator. “Lynozyfic has a convenient response-adapted dosing regimen, which provides the potential to extend time between doses. This is a significant patient-centric advancement that could help reduce treatment burden.” The FDA approval is based on results from the pivotal Phase 1/2 LINKER-MM1 trial investigating linvoseltamab in R/R MM in which patients (n=80) experienced a: 70% objective response rate (ORR), with 45% achieving a complete response (CR) or better, as determined by an independent review committee.0.95 month median time to first response (range: 0.5 to 6 months).Median duration of response (DoR) that was not reached (95% Confidence Interval [CI]: 12 months to not estimable). The estimated DoR was 89% at 9 months (95% CI: 77 to 95 months) and 72% at 12 months (95% CI: 54 to 84 months) among responders w...