The U.S. Food and Drug Administration (FDA) has granted accelerated approval to Lynozyfic (linvoseltamab-gcpt) for the treatment of adults with relapsed or refractory 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.
MM is a bone marrow-based plasma cell neoplasm characterized by a serum monoclonal protein and skeletal destruction. Common symptoms include osteolytic lesions, pathological fractures, bone pain, hypercalcemia, and anemia. The exact underlying cause of multiple myeloma is currently unknown.
Linvoseltamab is the first fully human BCMAxCD3 bispecific antibody approved by the FDA. The therapy is designed to bridge B-cell maturation antigen on MM cells with CD3-expressing T-cells to facilitate T-cell activation and cancer-cell killing.
The accelerated approval follows results from the LINKER-MMA clinical trial, an ongoing, open-label, multicenter, dose-escalation, phase 1/2 study of linvoseltamab in patients with R/R MM. A total of 80 patients experienced a 70% objective response rate, with 45% achieving a complete response or better with linvoseltamab. A 0.95 month media time to first response was observed, however a median duration of response was not reached but estimated to be 89% at 9 months and 72% at 12 months.
The prescribing information for linvoseltamab has a Boxed Warning for cytokine release syndrome and neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome, in addition to warnings and precautions for infections, neutropenia, hepatotoxicity and embryo-fetal toxicity.
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To learn more about MM and other rare cancers, visit https://checkrare.com/diseases/cancers/