WASHINGTON (dpa-AFX) - Regeneron Pharmaceuticals, Inc. (REGN) announced
Wednesday that the U.S. Food and Drug Administration has accepted for Priority
Review the Biologics License Application or BLA for linvoseltamab to treat
relapsed/refractory multiple myeloma or R/R MM that has progressed after at
least three prior therapies.

Multiple myeloma is the second most common blood cancer, and it is not curable
despite treatment advances. According to the firm, current treatments are able
to slow the progression of the cancer, while most patients will ultimately
experience disease progression and require additional therapies.

Linvoseltamab is an investigational bispecific antibody designed to bridge
B-cell maturation antigen on multiple myeloma cells with CD3-expressing T cells
to facilitate T-cell activation and cancer-cell killing.

The target action date for the FDA decision is August 22, 2024.

The BLA is supported by data from a Phase 1/2 pivotal trial (LINKER-MM1)
investigating linvoseltamab in R/R MM. Earlier this month, the European
Medicines Agency accepted for review the Marketing Authorization Application for
linvoseltamab in the same indication.

Regeneron noted that 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.

Linvoseltamab is currently under clinical development, and its safety and
efficacy have not been fully evaluated by any regulatory authority.

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