FDA Grants Accelerated Approval to Regeneron’s Lynozyfic for Advanced Multiple Myeloma

The U.S. Food and Drug Administration (FDA) has granted accelerated approval to Regeneron’s bispecific antibody linvoseltamab, now branded as Lynozyfic, for the treatment of relapsed or refractory multiple myeloma in patients who have received at least four prior lines of therapy. The regulatory clearance follows previous rejection in August 2024 due to manufacturing deficiencies at a third-party facility.
Lynozyfic joins a growing group of BCMAxCD3 bispecific antibodies approved for late-line multiple myeloma, including Johnson & Johnson’s Tecvayli, Pfizer’s Elrexfio, and J&J’s GPRC5DxCD3 engager Talvey. Despite entering the market later, Regeneron has emphasized dosing flexibility and efficacy as key differentiators.
Supported by data from the Phase I/II LINKER-MM1 study, Lynozyfic achieved a 70% overall response rate in the FDA-indicated population, with 45% of patients reaching a complete response or better. Among 80 patients receiving the 200 mg dose, 64% demonstrated a very good partial response or higher. Participants in this trial had received a median of five prior treatments.
Lynozyfic functions by binding to both BCMA and CD3 proteins, guiding T cells to target and eliminate multiple myeloma cells. It is the only bispecific in its class currently authorized to shift to once-monthly dosing following a very good partial response maintained over 24 weeks. According to Regeneron, this offers a unique convenience compared to Tecvayli and Elrexfio, which provide biweekly dosing for eligible responders.

Dr. Sundar Jagannath of Mount Sinai, who was involved in the LINKER-MM1 study, stated, “Lynozyfic has a convenient response-adapted dosing regimen. This is a significant patient-centric advancement that could help reduce treatment burden.”
Comparative trial results show Tecvayli with a 68% overall response rate, 63% achieving a very good partial response or better, and 31% reaching a complete response. For Elrexfio, those figures stood at 56%, 50%, and 25%, respectively. According to Regeneron’s Andres Sirulnik, Lynozyfic’s trial participants had higher tumor burdens than those in competing studies.
Safety remains a critical consideration for BCMA-targeted therapies. In the LINKER-MM1 trial, 46% of patients receiving Lynozyfic experienced cytokine release syndrome (CRS), with most cases being grade 1 or 2. CRS occurred more frequently in Tecvayli and Elrexfio trials, at 72% and 58%, respectively. All three therapies carry FDA-mandated boxed warnings for CRS and neurotoxicity, and initial treatment steps require hospitalization.
Severe infections were also observed during the study, with grade 3 or 4 infections in 38% of patients and a 4% fatal infection rate. Sirulnik noted that the severity and frequency of infections lessened significantly after the first six months of therapy, but emphasized that confirmation through a randomized trial is necessary.
A confirmatory Phase 3 trial, LINKER-MM3, comparing Lynozyfic to a regimen of Empliciti, Pomalyst, and dexamethasone, is fully enrolled and ongoing. Results from this trial could serve as the basis for full FDA approval.

Outside oncology, Regeneron is in early-stage development of linvoseltamab in combination with Dupixent to address severe food allergies. The company is also considering research into autoimmune diseases using BCMA-targeted agents, with more details expected in the future.
Lynozyfic’s approval marks a positive development for Regeneron in a year that has seen setbacks. In May, the company reported mixed results for itepekimab, an investigational antibody for chronic obstructive pulmonary disease, where one pivotal trial met its endpoint while another did not. BMO Capital Markets analysts acknowledged the impact on investor sentiment but described Lynozyfic’s clearance as a modest but timely gain. “But we are encouraged to see a quick win here heading into earnings,” they noted.