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# Regeneron BLA Resubmitted for Multiple Myeloma
- URL: https://www.fdaweb.com/regeneron-bla-resubmitted-for-multiple-myeloma/
- Published: 2025-02-11T12:00:00.000Z
- Updated: 2026-09-14T14:52:52.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158635

FDA has accepted for review a Regeneron Pharmaceuticals BLA resubmission for linvoseltamab for treating adult patients with relapsed/refractory multiple myeloma (R/R MM) that has progressed after at least three prior therapies. The user fee review action target date was set for 7/10.

Last August, the agency issued Regeneron a complete response letter on the BLA due to findings from a pre-approval inspection at a third-party fill/finish manufacturer for another company’s product candidate, the company said at the time. “The third-party fill/finish manufacturer has since informed Regeneron that it believes the findings have been resolved, their facility is awaiting reinspection by the FDA, and it is expected to take place in the coming months.” Regeneron now confirms that third-party fill/finish manufacturing issues have been resolved.

The submission is based on data from the Phase 1/2 pivotal trial (LINKER-MM1) [reported](https://www.globenewswire.com/Tracker?data=6QtBuF-ucfKLpmzHa-uNIG5KM7O0trZJ-N5Pun2Oq03inMq8Xh8xx4DflIVXXWRFGi8l4QReqXWIauWht6L1qaiunLerObCbZflHN8v5b5s8JA7uNgBzJZCjBo3ESuBpyLyTyqni0IAsz%5FYlPjQ9rTjvDpqkEPt95NYZPGUrbv96Oq0yJ3zilMt3n3W6CNwQZOUUgtelVx7N-pIsXH1CBw==&ref=fdaweb.com) in 12/2023\. Invoseltamab is described as an investigational bispecific antibody designed to bridge B-cell maturation antigen on multiple myeloma cells with CD3-expressing T cells to encourage T-cell activation and cancer-cell death. MM is the second most common blood cancer, with about 35,000 people diagnosed annually in the U.S.