The U.S. Food and Drug Administration (FDA) granted accelerated approval to Regeneron Pharmaceuticals, Inc.’s REGN Lynozyfic (linvoseltamab-gcpt) for adult patients with relapsed or refractory (R/R) multiple myeloma (MM) who have received at least four prior lines of therapy.
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.
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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 hours after the second step-up dose).
The FDA approval for linvoseltamab in R/R MM is based on the pivotal Phase 1/2 LINKER-MM1 trial. In this trial, patients (n=80) experienced a 70% objective response rate (ORR), with 45% achieving a complete response (CR) or better.
The median time to first response was 0.95 months. The median duration of response (DoR) was not reached. Among responders, the estimated DoR was 89% at 9 months and 72% at 12 months, with a median follow-up of 13 months.
The prescribing information for Lynozyfic includes a Boxed Warning for cytokine release syndrome and neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome, in addition to warnings and precautions for infections, neutropenia, hepatotoxicity, and embryo-fetal toxicity.
In other news for the company, and highlighting their broader portfolio of approved treatments, in June, the FDA approved Regeneron and Sanofi SA’s SNY Dupixent (dupilumab) for adult patients with bullous pemphigoid (BP), a rare, chronic autoimmune skin disorder.
BP primarily affects elderly patients and is characterized by intense itch, painful blisters and lesions, and skin reddening. It can be chronic and relapsing with underlying type 2 inflammation.
Price Action: REGN stock is trading higher by 0.24% to 549.06 at last check Thursday.
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