Investing.com -- Regeneron Pharmaceuticals (NASDAQ: REGN ) stock rose 2.8% after the U.S. Food and Drug Administration granted accelerated approval for the company’s blood cancer therapy Lynozyfic.
The FDA approved Lynozyfic (linvoseltamab-gcpt) to treat adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy. The approval was based on results from the Phase 1/2 LINKER-MM1 trial, which showed a 70% objective response rate among treated patients.
Lynozyfic is the first FDA-approved BCMAxCD3 bispecific antibody that can be dosed every two weeks starting at week 14, and potentially every four weeks if patients achieve a very good partial response or better after at least 24 weeks of therapy.
"The FDA approval of Lynozyfic represents meaningful progress for the multiple myeloma community. Lynozyfic demonstrated early, deep and durable responses in heavily pre-treated patients, which I saw firsthand in clinical trials," said Sundar Jagannath, Network Director of the Center of Excellence for Multiple Myeloma at Mount Sinai in New York City.
In the pivotal trial, 45% of patients achieved a complete response or better, with a median time to first response of 0.95 months. The median duration of response was not reached during the study period, with an estimated 72% of patients maintaining their response at 12 months.
The approval comes with a Boxed Warning for cytokine release syndrome and neurologic toxicity, along with other warnings for infections, neutropenia, hepatotoxicity and embryo-fetal toxicity.
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