Regeneron Pharmaceuticals’ Lynozyfic (linvoseltamab-gcpt) has been granted accelerated approval by the US Food and Drug Administration (FDA) to treat adults with relapsed or refractory multiple myeloma (MM).
Patients eligible for the drug will have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti‑CD38 monoclonal antibody.
More than 36,000 new cases of MM, an incurable blood cancer, are expected to be diagnosed in the US this year.
Despite advances in treatment, there are around 8,000 MM patients in the US whose disease has progressed after three lines of therapy, and 4,000 whose disease has progressed after four or more therapies.
Regeneron’s Lynozyfic is a bispecific antibody that works by bridging B-cell maturation antigen on MM cells with CD3-expressing T cells to drive T-cell activation and cancer-cell killing.
The FDA’s decision on the drug was based on results from the phase 1/2 LINKER-MM1 trial, which demonstrated a 70% objective response rate and complete rate of 45%.
Median time to first response was 0.95 months, while median duration of response (DoR) was not reached. Estimated DoR was 89% at nine months and 72% at 12 months among responders who had a median follow-up of 13 months.
Regeneron’s president and chief scientific officer, George Yancopoulos, said: “With a 70% overall response rate in heavily pre-treated patients, we believe Lynozyfic is poised to potentially become a new standard of care for MM.”
In line with the FDA’s accelerated approvals pathway, continued approval for Lynozyfic in this indication may be contingent on the verification of clinical benefit in a confirmatory trial.
Beyond R/R MM, Lynozyfic is currently being evaluated across different lines of therapy in the disease, including earlier lines of treatment, as well as MM precursor and other plasma cell disorders.
“Given the strength of the data, we are rapidly advancing our broad clinical development programme for Lynozyfic – exploring its use in earlier lines of therapy as monotherapy and in novel combinations – as we aim to meaningfully advance care for patients,” Yancopoulos said.