Regeneron Gets CHMP Backing of Linvoseltamab

Regeneron Gets Positive CHMP Opinion for Multiple Myeloma Drug
Regeneron Pharmaceuticals, Inc. REGN obtained positive opinion for its pipeline candidate linvoseltamab from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP).
Regeneron announces EMA CHMP adopted positive opinion on linvoseltamab
Pharmaceuticals announced that the European Medicines Agency’s, EMA, Committee for Medicinal Products for Human Use, CHMP, has
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.
Regeneron's linvoseltamab gets positive EU regulatory opinion
Regeneron Pharmaceuticals (NASDAQ:REGN) said the European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended conditional marketing authorization of its drug linvoseltamab for the treatment of adults with relapsed and refractory multiple myeloma.
Linvoseltamab Under Review for Relapsed/Refractory Multiple Myeloma
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 issues. According to Regeneron, these issues have since been resolved.
Linvoseltamab Recommended for EU Approval by the CHMP to Treat Relapsed/Refractory Multiple Myeloma
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 ...
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Regeneron's Linvoseltamab Receives Positive CHMP Opinion For Treating Relapsed/Refractory MM
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 ...
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Linvoseltamab BLA Resubmission Accepted by FDA for Review
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 ...
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Linvoseltamab BLA Accepted for FDA Review for the Treatment of Relapsed/Refractory Multiple Myeloma
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 ...