FDA accepts BLA for Regeneron’s linvoseltamab for Priority Review
Betsy Goodfellow | February 22, 2024 | News story | Medical Communications | FDA, Oncology, Regeneron, bla, priority review
Regeneron Pharmaceuticals has announced that the US Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for Priority Review for linvoseltamab for the treatment of adult patients with relapsed/refractory (R/R) multiple myeloma (MM) that has progressed after at least three prior therapies.
The FDA has given a target action date for its decision of 22 August 2024.
The drug is an investigational bispecific antibody intended to bridge B-cell maturation antigen on MM cells with CD3-expresing T-cells to facilitate T-cell activation and cancer-cell killing.
The BLA follows data from the phase 1/2 LINKER-MM1 trial which investigated the drug in R/R MM which was shared in December 2023. The European Medicines Agency (EMA) also accepted for review a Marketing Authorisation Application for the drug in the same indication.
According to the company’s press release: “The linvoseltamab clinical development program includes a phase 3 confirmatory trial in patients with R/R MM (LINKER-MM3) that is currently enrolling. Additional trials in earlier lines of therapy and stages of disease are planned or underway, including a phase 1/2 trial in the first-line setting, a phase 2 trial in high-risk smoldering MM and a phase 2 trial in monoclonal gammopathy of undetermined significance. A phase 1 trial of linvoseltamab in combination with a Regeneron CD38xCD28 costimulatory bispecific in MM is also planned.”
Betsy Goodfellow
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