Regeneron Pharmaceuticals, Inc. has achieved a significant milestone with the U.S. Food and Drug Administration (FDA) granting Accelerated Approval to Lynozyfic™ (linvoseltamab-gcpt). This cutting-edge bispecific antibody is now approved for adult patients living with relapsed or refractory (R/R) multiple myeloma (MM) who have already undergone at least four prior lines of therapy, including specific classes of drugs like proteasome inhibitors, immunomodulatory agents, and anti-CD38 monoclonal antibodies. This approval marks a pivotal moment for patients suffering from this challenging blood cancer, offering a new, highly effective therapeutic option.

Lynozyfic works by ingeniously bridging B-cell maturation antigen (BCMA) on multiple myeloma cancer cells with CD3-expressing T cells. This connection effectively directs the patient's own T cells to activate and kill the cancer cells, harnessing the immune system's power to fight the disease. The FDA's decision was largely based on compelling data from the pivotal Phase 1/2 LINKER-MM1 trial. In this study, heavily pre-treated patients demonstrated remarkable efficacy, with an objective response rate (ORR) of 70% and an impressive 45% achieving a complete response (CR) or better. These results are among the highest reported for bispecific antibodies in this difficult-to-treat population, highlighting Lynozyfic's profound impact.

A notable feature of Lynozyfic is its patient-centric response-adapted dosing regimen. After an initial step-up dosing period (which requires brief hospitalization for safety monitoring), patients can transition to an every-two-week dosing schedule starting at week 14. For those who achieve and maintain a very good partial response (VGPR) or better after at least 24 weeks of therapy, the dosing can be further extended to every four weeks. This flexibility aims to reduce the burden of frequent hospital visits and infusions, significantly improving patients' quality of life.

While offering substantial benefits, Lynozyfic does come with important safety considerations. Its prescribing information includes a Boxed Warning for cytokine release syndrome (CRS) and neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome (ICANS). Other warnings encompass infections, neutropenia, and hepatotoxicity. Consequently, Lynozyfic is available only through a restricted program called the Lynozyfic Risk Evaluation and Mitigation Strategy (REMS) to ensure patient safety through careful monitoring and management of these potential side effects.

This approval reinforces the strength of Regeneron's bispecific antibody program and their commitment to the cancer community. Given the robust data, Regeneron is actively pursuing a broad clinical development program for Lynozyfic, exploring its use in earlier lines of therapy as both monotherapy and in combination with other treatments, with the ultimate goal of further transforming care for multiple myeloma patients worldwide. The company has also launched Lynozyfic Surround™ to provide financial and educational resources to support patients throughout their treatment journey.