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# Positive Phase 1/2 Linvoseltamab Results to FDA
- URL: https://www.fdaweb.com/positive-phase-1-2-linvoseltamab-results-to-fda/
- Published: 2023-12-07T12:00:00.000Z
- Updated: 2026-09-14T14:18:03.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155938

Regeneron says it will submit positive Phase 1/2 trial results of its linvoseltamab in multiple myeloma to FDA and is on track to submit a BLA to the agency this year. A company [statement](https://investor.regeneron.com/news-releases/news-release-details/updated-linvoseltamab-pivotal-data-demonstrated-strong-rates-and?ref=fdaweb.com) says the primary endpoint analysis from the LINKER-MM1 trial “demonstrated high rates of deep and durable responses in patients with relapsed/refractory multiple myeloma.”

Linvoseltamab is described as an investigational BCMAxCD3 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. FDA has granted the drug fast-track designation for multiple myeloma.