Regeneron Pharmaceuticals has received accelerated FDA approval for Lynozyfic, a new bispecific antibody treatment for adults with relapsed or refractory multiple myeloma who have undergone at least four prior therapies, the agency said July 2.
The approval is based on results from a phase 1 and 2 trial, which showed a 70% overall response rate, with 45% of patients achieving a complete response or better, according to a July 2 news release from the drugmaker.
Lynozyfic works by binding to both B cell maturation antigen on cancerous plasma cells and CD3 on T cells, directing the immune system to kill the cancer cells. It is the first bispecific antibody approved by the FDA that can be dosed every two weeks beginning at week 14 and potentially every 14 weeks for patients who respond well after 24 weeks of treatment, the company said.
The drug will be available under a restricted Risk Evaluation and Mitigation Strategy program, the FDA said.
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