Regeneron’s linvoseltamab gains EMA filing acceptance for R/R MM treatment

Betsy Goodfellow | February 5, 2024 | News story | Medical Communications EMA, Oncology, Regeneron, linvoseltamab, multiple myeloma 

Regeneron Pharmaceuticals has announced that the European Medicines Agency (EMA) has accepted for review its Marketing Authorisation Application (MAA) for linvoseltamab for the treatment of adult patients with relapsed/refractory (R/R) multiple myeloma (MM) who have progressed after at least three previous treatments.

The drug is an investigational bispecific antibody which has been designed to connect B-cell maturation antigen (BCMA) on MM cells with CD3-expressing T-cells in order to activate the T-cells and kill the cancer cells.

The MAA follows data from a phase 1/2 pivotal trial which investigated the drug in R/R MM, with data having been shared in December 2023. The company also submitted a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) in December 2023.

According to the company’s press release: ‘The linvoseltamab clinical development programme includes a phase 3 confirmatory trial (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 CD38xCD28 costimulatory bispecific in MM is also planned’.

Betsy Goodfellow

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