Regeneron Pharmaceuticals, Inc. (REGN) has announced that the European Medicines Agency's Committee for Medicinal Products for Human Use or CHMP has issued a positive opinion recommending conditional marketing authorization for linvoseltamab in treating adults with relapsed and refractory or R/R multiple myeloma or MM. This recommendation applies to patients 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 treatment.
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 bispecific antibody that activates T-cells to target and kill MM cells.
The FDA has also accepted the Biologics License Application for linvoseltamab, with a decision expected on July 10, 2025.
This recommendation represents a crucial step in providing a new therapeutic option for R/R MM patients, a group with limited treatment alternatives.
Regeneron is awaiting a final decision from the European Commission in the coming months.
Currently, REGN is trading at $700 down by 0.39 percent on the Nasdaq.
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