Regeneron Secures FDA Approval For Lynozyfic In Heavily Pretreated Myeloma Patients

Regeneron Pharmaceuticals has received accelerated approval from the U.S. FDA for Lynozyfic™ (linvoseltamab-gcpt), a first-in-class BCMAxCD3 bispecific antibody for adult patients with relapsed or refractory multiple myeloma (R/R MM) who have undergone at least four prior treatments. The decision is based on the positive response rates and durability of response observed in the pivotal Phase 1/2 LINKER-MM1 trial, with continued approval contingent on confirmation from ongoing studies.

“The FDA approval of Lynozyfic represents meaningful progress for the multiple myeloma community. Lynozyfic demonstrated early, deep and durable responses in heavily pre-treated patients, which I saw firsthand in clinical trials. Lynozyfic has a convenient response-adapted dosing regimen, which provides the potential to extend time between doses. This is a significant patient-centric advancement that could help reduce treatment burden,” said Sundar Jagannath, M.D., Network Director of the Center of Excellence for Multiple Myeloma at Mount Sinai in New York City and a trial investigator.

Lynozyfic demonstrated a 70% overall response rate among treated patients, with 45% achieving a complete response or better. The median time to response was under one month, and the median duration of response was not yet reached, with 72% of responders maintaining benefit after 12 months. The therapy introduces a flexible maintenance schedule, initially administered every two weeks starting at week 14 and then every four weeks upon achieving a very good partial response or better after 24 weeks.

“The FDA approval of Lynozyfic reinforces the strength of our bispecific antibody program as well as our commitment to delivering critical medicines to the cancer community. With a 70% overall response rate in heavily pre-treated patients, we believe Lynozyfic is poised to potentially become a new standard of care for multiple myeloma. Furthermore, given the strength of the data, we are rapidly advancing our broad clinical development program for Lynozyfic – exploring its use in earlier lines of therapy as monotherapy and in novel combinations – as we aim to meaningfully advance care for patients,” said George D. Yancopoulos, M.D., Ph.D., Board co-Chair, President and Chief Scientific Officer of Regeneron. 

The product’s label carries a Boxed Warning for cytokine release syndrome (CRS) and neurological toxicities, including ICANS. Additional precautions include risks of infection, cytopenias, hepatotoxicity, and embryo-fetal toxicity. Lynozyfic is available under a Risk Evaluation and Mitigation Strategy (REMS) program and is supported by Lynozyfic Surround™, a patient access initiative offering financial support and educational resources.

“Even though the number of treatment options for multiple myeloma has expanded in recent years, it remains an incurable disease with considerable unmet need, especially among patients who have undergone multiple lines of treatment. The FDA approval of Lynozyfic is a welcome milestone. It provides appropriate multiple myeloma patients and their care teams with a novel patient-centric treatment option that includes a dosing schedule that can be adapted based on patient response. We appreciate Regeneron’s continued research to further advance treatment for this community,” said Diane Moran, R.N., M.A., Ed.M., Chief Executive Officer (Interim) and Senior Vice President of Strategic Planning at the International Myeloma Foundation.