Regeneron’s Lynozyfic™ Secures FDA Accelerated Approval for Heavily Pretreated Multiple Myeloma Patients
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Lynozyfic™ (linvoseltamab-gcpt) for the treatment of adult patients with relapsed or refractory (R/R) multiple myeloma (MM) who have undergone at least four prior lines of therapy. Eligible prior treatments include a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.
Approval was based on objective response rate (ORR) and duration of response (DoR) observed in the Phase 1/2 LINKER-MM1 trial. Continued approval may depend on confirmation of clinical benefit in ongoing trials.
A First-in-Class Dosing Innovation
Lynozyfic is now the first FDA-approved BCMAxCD3 bispecific antibody that can be administered every two weeks starting from week 14, and as infrequently as every four weeks if a very good partial response (VGPR) or better is achieved after 24 weeks. The unique response-adapted dosing schedule aims to reduce treatment burden for patients and is paired with hospitalization protocols for the initial “step-up” doses to monitor for serious adverse events.
“This approval marks real progress for the multiple myeloma community,” said Dr. Sundar Jagannath of Mount Sinai, a clinical investigator in the trial. “The depth and speed of responses in patients who were heavily pretreated is notable. Lynozyfic’s ability to allow extended intervals between doses is a significant patient-centric advancement.”
LINKER-MM1 Trial Highlights
The approval stems from results in 80 patients in the pivotal LINKER-MM1 trial, which demonstrated:
- 70% ORR, with 45% achieving complete response (CR) or better
- Median time to first response of just 0.95 months
- Median DoR not yet reached, with estimated 89% DoR at 9 months and 72% at 12 months among responders
These early but durable responses offer hope to patients with few remaining treatment options.
Safety Profile and REMS Program
Due to the potential for serious side effects, Lynozyfic includes a Boxed Warning for cytokine release syndrome (CRS) and neurologic toxicities, including immune effector cell-associated neurotoxicity syndrome (ICANS). Other common adverse events (≥20%) included:
- Musculoskeletal pain
- CRS
- Cough and respiratory infections
- Fatigue, diarrhea, nausea, and pneumonia
The most common Grade 3/4 laboratory abnormalities (≥30%) were decreases in lymphocytes, neutrophils, hemoglobin, and white blood cells.
Lynozyfic is available only through the REMS (Risk Evaluation and Mitigation Strategy) program. Patients are issued a wallet card to alert medical professionals of potential risks during emergencies.
Industry and Patient Advocacy Reactions
Dr. George Yancopoulos, Regeneron’s President and Chief Scientific Officer, emphasized the milestone: “With a 70% response rate in patients with limited options, Lynozyfic could evolve into a new standard of care for advanced multiple myeloma. We’re also advancing its development in earlier treatment lines and in combination therapies.”
Diane Moran, R.N., Interim CEO of the International Myeloma Foundation, highlighted the approval’s importance: “Multiple myeloma remains incurable despite new therapies. Lynozyfic’s adaptive schedule and novel mechanism provide a new hope for patients and caregivers.”
To support access, Regeneron has launched Lynozyfic Surround™, a program offering financial and educational resources. Patients can call 1-844-RGN-HEME (1-844-746-4363) for assistance.
About Multiple Myeloma
Multiple myeloma is the second most common blood cancer, with over 187,000 cases globally each year. In the U.S. alone, 36,000 new diagnoses and 12,000 deaths are expected in 2025. Despite treatment advances, the disease remains incurable, with most patients experiencing relapses after several lines of therapy. Approximately 8,000 U.S. patients have MM that has progressed after three lines of treatment, and 4,000 after four or more.
About Lynozyfic (linvoseltamab-gcpt)
Lynozyfic is a fully human bispecific antibody, developed using Regeneron’s VelocImmune® technology. It targets BCMA on myeloma cells and CD3 on T-cells, effectively bridging immune cells to initiate cancer cell killing.
The therapy is administered via intravenous infusion, starting with a step-up dosing schedule followed by weekly dosing. After 14 weeks, dosing transitions to every 2 weeks and potentially every 4 weeks with sustained response.
Hospitalization is required for 24 hours after each of the first two step-up doses to monitor for potential CRS or neurotoxicity.
Clinical Development Program
The ongoing LINKER-MM1 study includes over 300 patients and is assessing IV and subcutaneous formulations of linvoseltamab. The Phase 2 portion is measuring safety, overall response rate, progression-free survival, and other efficacy metrics.
Important Safety Information
Patients should inform their healthcare providers if they:
- Are pregnant, plan pregnancy, or are breastfeeding
- Have existing infections
- Are taking any other medications or supplements
Lynozyfic may cause:
- Severe infections including pneumonia
- Liver toxicity and abnormal liver tests
- Decreased white and red blood cell counts
Patients should avoid driving or operating heavy machinery for 48 hours after step-up doses or if experiencing neurologic symptoms.
