Lynozyfic receives EU approval for relapsed multiple myeloma treatment

New therapy offers hope for patients with limited option

Regeneron Pharmaceuticals has announced that the European Commission has conditionally approved Lynozyfic (linvoseltamab) for adults with relapsed and refractory multiple myeloma. This approval targets patients who have undergone at least three prior treatments and whose disease has progressed.

Lynozyfic is a bispecific antibody that activates T cells to eliminate cancerous plasma cells. It is the first BCMAxCD3 therapy to offer a response-adapted schedule, with dosing every four weeks after achieving a very good partial response or better following 24 weeks of therapy.

The approval is based on data from the LINKER-MM1 trial. Results showed a 71% objective response rate, with 50% achieving complete or stringent complete responses. The median duration of response was 29 months. Key findings included a minimal residual disease negativity rate of 41% in patients with complete responses.

Common adverse reactions included musculoskeletal pain, cytokine release syndrome, and neutropenia. Most cytokine release syndrome cases were mild or moderate, with no Grade 4 cases reported.

Dr Paula Rodriguez-Otero from Clínica Universidad de Navarra said: “In a clinical trial, linvoseltamab demonstrated compelling and impressive efficacy with the potential for complete remission in this patient population, including those with high disease burden.”

This marks Regeneron’s second bispecific antibody approval. George Yancopoulos, President of Regeneron, noted: “We are excited by the potential of Lynozyfic and its differentiated clinical profile.”

Lynozyfic offers hope to the 35,000 Europeans diagnosed annually with multiple myeloma, a blood cancer that remains incurable despite treatment advances. Regeneron is also pursuing its development in other settings to improve outcomes for more patients globally.