Regeneron Gets CHMP Backing of Linvoseltamab
Regeneron Gets CHMP Backing of Linvoseltamab in Multiple Myeloma
Regeneron on Friday said the recommendation covers adults with adults with relapsed and refractory multiple myeloma who have received at least three prior therapies, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody, and have shown disease progression on the last therapy.
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The positive CHMP opinion is supported by data from the pivotal LINKER-MM1 trial, which evaluated linvoseltamab in adults with R/R MM. Earlier this month, the FDA accepted for review the Biologics ...
Linvoseltamab is an investigational B-cell maturation antigen CD3-targeted bispecific antibody. The BLA resubmission was needed as the original application could not be approved due to manufacturing ...
The positive opinion follows results from the pivotal LINKER-MM1 trial, which demonstrated linvoseltamab's effectiveness in this patient population. Linvoseltamab is an investigational BCMAxCD3 ...
Linvoseltamab's BLA resubmission is under FDA review, with a decision anticipated by July 2025, supported by LINKER-MM1 trial data. The trial evaluates linvoseltamab's safety, tolerability, and ...
The BLA is supported by data from the pivotal LINKER-MM1 trial investigating linvoseltamab in R/R MM, and linvoseltamab is also under review by the European Medicines Agency (EMA) for the same ...
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