Lynozyfic™ Gains FDA Accelerated Approval for Relapsed/Refractory Multiple Myeloma

Regeneron Pharmaceuticals has announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Lynozyfic™ (linvoseltamab-gcpt) as a treatment option for adult patients with relapsed or refractory multiple myeloma who have undergone at least four previous lines of therapy. These previous treatments must include a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. Lynozyfic represents a significant step in multiple myeloma care and is the first FDA-approved BCMAxCD3 bispecific antibody with a patient-centric response-adapted dosing schedule. It allows dosing every two weeks starting at the 14th week of treatment and extends to every four weeks for those achieving a very good partial response or better after 24 weeks.

The approval stems from promising results in the pivotal Phase 1/2 LINKER-MM1 trial, where Lynozyfic demonstrated robust efficacy with a high overall response rate of 70% and a complete response rate of 45% among heavily pre-treated patients. Lynozyfic's regimen includes an initial hospitalization period for safety monitoring during step-up dosing due to potential adverse reactions such as cytokine release syndrome (CRS) and neurologic toxicity.

Dr. Sundar Jagannath, a trial investigator and director of the Center of Excellence for Multiple Myeloma at Mount Sinai, highlighted the importance of Lynozyfic's approval as it showcases impressive early and sustained responses in patients who have previously undergone multiple treatments. The dosing regimen is adaptable based on patient response, potentially easing the treatment burden and extending intervals between doses, which emphasizes patient-centric care in oncology.

Regeneron’s commitment to advancing cancer treatment is underscored by Lynozyfic’s approval. The company is actively pursuing a broad clinical development program to explore Lynozyfic's application in earlier treatment lines as both a monotherapy and in combination with other therapies. George D. Yancopoulos, Regeneron's President and Chief Scientific Officer, expressed optimism about Lynozyfic potentially setting a new standard of care for multiple myeloma due to the compelling trial results.

Lynozyfic is made accessible through Regeneron’s support program, Lynozyfic Surround™, which provides financial and educational assistance to patients during their treatment journey. This aligns with Regeneron's dedication to ensuring patients benefit from their innovations in medical care.

Despite advancements, multiple myeloma remains an incurable disease with significant unmet needs, especially for those who have exhausted multiple treatment lines. With over 187,000 new global cases annually, and approximately 12,000 deaths expected in the U.S. alone by 2025, the approval of Lynozyfic presents a promising option for patients and healthcare providers.

Lynozyfic, developed using Regeneron’s VelocImmune technology, is a fully human bispecific antibody designed to target multiple myeloma cells. It connects B-cell maturation antigen (BCMA) on tumor cells with CD3-expressing T cells to promote cancer cell destruction. The innovative approach harnesses T-cell activation to provide therapeutic effects in combating multiple myeloma.

Ultimately, Regeneron's efforts in hematology aim to deliver cutting-edge treatments for blood cancers and rare disorders. Lynozyfic's development and approval showcase the potential of bispecific antibodies in transforming cancer care, reinforcing Regeneron’s role in pioneering treatment options and advancing medical research.