Regeneron Showcases Updated on BLA for Linvoseltamab to Treat R/R Multiple Myeloma (MM)
Shots:
- The US FDA has issued a CRL related to the BLA for Linvoseltamab for the treatment of 3L+ r/r MM. Regeneron presented results and during its Q2’24 earnings call.
- As per Regeneron, pre-approval inspection at a third-party fill/finish manufacturer has been completely and awaiting FDA re-inspection in next few months and expecting to receive resolution and approval.
- Linvoseltamab is a bispecific antibody that promotes the interaction of BCMA x CD-3 expressing T-cell on MM cells. Regeneron's Linvoseltamab is under regulatory review by the EMA for the same indication
Ref: Regeneron | Image: Regeneron
Related News:- Regeneron Showcases Updated P-I/II (LINKER-MM1) Study Data of Linvoseltamab for Treating R/R Multiple Myeloma at EHA 2024
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