Regeneron Receives FDA Accelerated Approval for Lynozyfic™ in Relapsed or Refractory Multiple Myeloma
Thursday, July 03, 2025
Regeneron Pharmaceuticals has received accelerated approval from the U.S. Food and Drug Administration (FDA) for Lynozyfic™ (linvoseltamab-gcpt), a bispecific antibody developed for the treatment of adult patients with relapsed or refractory multiple myeloma (MM).
Multiple myeloma is the second most common type of blood cancer. Globally, it affects more than 187,000 individuals annually, with over 36,000 new cases expected in the US alone in 2025. While several therapies are available, the disease remains incurable, particularly in patients who have already received multiple treatments. An estimated 4,000 patients in the US have progressed after four or more prior therapies.
Lynozyfic was developed using Regeneron’s VelocImmune® platform and is designed to bring together BCMA-expressing myeloma cells and CD3-expressing T cells to promote cancer cell destruction.
The approval applies to individuals who have previously received at least four lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.
This approval is based on data from the Phase 1/2 LINKER-MM1 clinical trial, which demonstrated a 70% objective response rate among participants. Notably, 45% of patients achieved a complete response or better.
Lynozyfic is the first BCMAxCD3 bispecific antibody approved by the FDA that allows for extended dosing intervals. Starting from week 14, patients may receive doses every two weeks, and every four weeks if a very good partial response or better is achieved after 24 weeks of therapy. The treatment regimen includes two separate 24-hour hospital stays during the initial step-up dosing phase for safety monitoring.
The prescribing information includes a boxed warning due to risks of cytokine release syndrome (CRS) and neurological side effects, such as immune effector cell-associated neurotoxicity syndrome. Other precautions include the potential for infections, neutropenia, liver toxicity, and risks to unborn babies.
The most common side effects reported in the trial were musculoskeletal pain, CRS, cough, fatigue, diarrhoea, pneumonia, and respiratory tract infections. Frequently observed laboratory abnormalities included reduced levels of lymphocytes, neutrophils, haemoglobin, and white blood cells.
To support patient access, Regeneron has launched a programme called Lynozyfic Surround™, providing financial and educational resources. The product is available only through the Lynozyfic Risk Evaluation and Mitigation Strategy (REMS), a restricted distribution programme in the United States.
Regeneron is also expanding the clinical development of linvoseltamab to evaluate its potential in earlier treatment settings and in combination with other therapies.
Source: regeneron.com
