April 28, 2025—According to a press release from Regeneron Pharmaceuticals Inc., "the European Commission (EC) has granted conditional marketing approval of Lynozyfic™ (linvoseltamab) to treat adults with relapsed and refractory (R/R) multiple myeloma (MM). The indication is specific to those who have received at least three prior therapies, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody, and have demonstrated disease progression on the last therapy. Lynozyfic is a bispecific antibody designed to bridge B-cell maturation antigen (BCMA) on MM cells with CD3-expressing T cells to facilitate T-cell activation and cancer-cell killing."

The European Commission approval is supported by data from the pivotal LINKER-MM1 trial, which evaluated 117 patients treated with the 200 mg dose of Lynozyfic. The study demonstrated strong and lasting responses in patients with relapsed or refractory multiple myeloma (R/R MM). An independent review committee confirmed an objective response rate (ORR) of 71%, with 50% of patients achieving a complete response (CR) or better. Among those who reached a CR or stringent CR, 41% (24 of 58 patients; 95% confidence interval [CI]: 29–55) were minimal residual disease (MRD) negative. The median duration of response (DOR) was 29 months (95% CI: 19 months to not estimable).

Read the full press release from the button below.