Regeneron Pharmaceuticals (NASDAQ:REGN) saw its stock increase by 2.8% after the U.S. Food and Drug Administration granted accelerated approval for its new blood cancer drug, Lynozyfic.
Lynozyfic (linvoseltamab-gcpt) is now approved to treat adults with relapsed or refractory multiple myeloma who have undergone at least four previous treatment regimens. The FDA’s decision was supported by data from the Phase 1/2 LINKER-MM1 trial, which reported an impressive 70% objective response rate among participants.
Notably, Lynozyfic is the first FDA-approved bispecific antibody targeting BCMA and CD3, with a dosing schedule starting every two weeks from week 14, and potentially extending to every four weeks for patients achieving a very good partial response or better after 24 weeks of therapy.
Sundar Jagannath, Network Director at Mount Sinai’s Center of Excellence for Multiple Myeloma, praised the approval, stating, “Lynozyfic offers significant advancement for multiple myeloma patients, showing rapid, deep, and sustained responses even in heavily pretreated individuals.”
Within the trial, 45% of patients reached complete response or better, with a median time to initial response of less than one month (0.95 months). The duration of response had not been reached by study’s end, with an estimated 72% of patients maintaining response at 12 months.
The FDA approval includes a Boxed Warning for risks such as cytokine release syndrome and neurological toxicities, along with additional warnings regarding infections, neutropenia, liver toxicity, and embryo-fetal harm.