FDA Grants Accelerated Approval to Regeneron's Lynozyfic for Multiple Myeloma Treatment

Regeneron Pharmaceuticals has received accelerated approval from the US Food and Drug Administration (FDA) for its drug Lynozyfic (linvoseltamab-gcpt), intended for adults with relapsed or refractory multiple myeloma (MM). This approval marks a significant development for patients who have previously undergone at least four different treatments, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

Multiple myeloma is a challenging and incurable form of blood cancer, with projections suggesting over 36,000 new cases will be identified in the US within the year. Despite the progress in available treatments, a significant number of patients—approximately 8,000—experience disease progression after three therapeutic interventions. Furthermore, around 4,000 patients face progression after exhausting four or more treatment options.

Lynozyfic distinguishes itself as a bispecific antibody. Its mechanism involves targeting the B-cell maturation antigen on multiple myeloma cells and linking it with T cells that express CD3. This interaction aims to activate T cells, which in turn work to eliminate the cancer cells.

The FDA's green light for Lynozyfic was influenced by promising results from the phase 1/2 LINKER-MM1 clinical trial. The trial reported an objective response rate of 70%, with 45% of patients achieving complete response. The median time to first response was approximately 0.95 months. While the median duration of response was not fully established, estimates showed a duration of response at 89% after nine months and 72% at twelve months for patients who were followed for a median period of 13 months.

George Yancopoulos, Regeneron's president and chief scientific officer, expressed optimism about Lynozyfic's potential impact, noting the high overall response rate among heavily pre-treated patients. He suggested that Lynozyfic might emerge as a new standard of care in the treatment landscape for multiple myeloma.

The approval through the FDA’s accelerated pathway means that continued endorsement of Lynozyfic for this specific use might depend on the outcome of further clinical trials meant to confirm its clinical benefits. Regeneron is actively pursuing additional research on Lynozyfic, exploring its efficacy in various stages of treatment beyond the relapsed or refractory stages. This includes studying its application in earlier lines of therapy, as well as its potential in managing MM precursors and other related plasma cell disorders.

Yancopoulos highlighted the importance of the data obtained so far, emphasizing a commitment to expanding the clinical development program for Lynozyfic. The goal is to assess its effectiveness as a standalone therapy and in innovative combination treatments, with the overarching aim of significantly enhancing care options for multiple myeloma patients.