FDA has granted approval to Regeneron Pharmaceuticals, Linvoseltamab, a novel bispecific antibody, for treating adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least 3 prior lines of therapy.
This approval is based on data from the phase 1/2 LINKER-MM1 clinical trial for linvoseltamab, a step forward for patients suffering from RRMM.
Linvoseltamab’s approval marked a crucial milestone in treating RRMM, offering a new option for patients with limited choices.
Additionally, the FDA has also granted orphan drug designation (ODD) to linvoseltamab for treating RRMM.
This designation provides specific incentives to encourage the development of drugs for rare diseases.
Linvoseltamab is being co-developed by Regeneron and Sanofi. The drug will be available to RRMM patients in the United States in the coming weeks.
Source: Regeneron Provides Update on Biologics License Application for Linvoseltamab
https://investor.regeneron.com/news-releases/news-release-details/regeneron-provides-update-biologics-license-application-0
