By Fineline Cube 
US-based Regeneron Pharmaceuticals Inc., (NASDAQ: REGN) announced that it has received accelerated approval from the US Food and Drug Administration (FDA) for its Lynozyfic (linvoseltamab-gcpt). The drug is indicated for the treatment of adult patients with relapsed or refractory (R/R) multiple myeloma (MM) who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. This approval makes Lynozyfic the first FDA-approved BCMAxCD3 bispecific antibody (BsAb).
Clinical Trial Results
The FDA’s decision was based on results from the open-label, multicenter Phase 1/2 LINKER-MM1 trial. Lynozyfic demonstrated high response rates in heavily pretreated multiple myeloma patients, with an overall response rate (ORR) of 70% and a complete response (CR) rate of 45%.
Adverse Reactions and Availability
Common adverse reactions (≥20%) include musculoskeletal pain, cytokine release syndrome (CRS), cough, upper respiratory infection, diarrhea, fatigue, pneumonia, nausea, headache, and dyspnea. Frequent Grade 3 or 4 laboratory abnormalities (≥30%) include decreased lymphocyte count, decreased neutrophil count, decreased hemoglobin, and decreased white blood cell count. Lynozyfic is available only through a restricted program called the Lynozyfic REMS (Risk Evaluation and Mitigation Strategy).-Fineline Info & Tech