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Linvoseltamab FDA Approval Status

Last updated by Judith Stewart, BPharm on Aug 21, 2024.

FDA Approved: No
Generic name: linvoseltamab
Company: Regeneron Pharmaceuticals, Inc.
Treatment for: Multiple Myeloma

Linvoseltamab is a BCMAxCD3 bispecific antibody in development for the treatment of relapsed/refractory multiple myeloma.

Development timeline for linvoseltamab

DateArticle
Aug 20, 2024Regeneron Provides Update on Biologics License Application for Linvoseltamab
Jun 16, 2024Updated Linvoseltamab Data Showcase Continued Deepening of Responses in Patients with Heavily Pre-Treated Multiple Myeloma
Apr  7, 2024Linvoseltamab Pivotal Data Presented at AACR Reinforce High Response Rate that Deepens Over Time in Patients with Heavily Pre-Treated Multiple Myeloma
Feb 21, 2024Linvoseltamab BLA for Treatment of Relapsed/Refractory Multiple Myeloma Accepted for FDA Priority Review
Dec  7, 2023Updated Linvoseltamab Pivotal Data Demonstrated Strong Rates and Depth of Response in Patients with Heavily Pre-Treated Multiple Myeloma
May 25, 2023Updated Linvoseltamab (BCMAxCD3) Data from Pivotal Trial Demonstrates Early, Deep and Durable Responses in Patients with Heavily Pre-treated Multiple Myeloma
Dec 12, 2022Linvoseltamab (BCMAxCD3) Initial Pivotal Phase 2 Data Show Clinically Meaningful Responses in Patients with Heavily Pre-treated Multiple Myeloma
Dec 11, 2021New REGN5458 (BCMAxCD3) Phase 1 Data Show 75% Response Rate at Highest Dose Levels Studied in Patients with Heavily Pretreated Multiple Myeloma
Dec  5, 2020Regeneron's BCMAxCD3 Bispecific Antibody (REGN5458) Shows Deep and Durable Responses in Patients with Heavily-pretreated Multiple Myeloma in Phase 1
Dec  8, 2019First Clinical Data for REGN5458 (BCMAxCD3) Show Positive Preliminary Results in Multiple Myeloma

Further information

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