Regeneron Reports the Acceptance of its MAA by the EMA for Linvoseltamab to Treat Multiple Myeloma (MM)
Shots:
- The MAA was submitted based on the data from the P-I/II (LINKER-MM1) trial evaluating Linvoseltamab (200mg) in patients (n=282) with r/r MM. The 1EPs were safety, tolerability & dose-limiting toxicities across 9 dose levels & 2EPs were DoR, PFS & OS
- At a median follow-up of 11mos, the study depicted an ORR of 71% & CR in 46% of patients whereas following 24wks. of treatment, patients who achieved VGPR or better, shifted from a Q2W dosing to a Q4W dosing. The data were presented at the ASH 2023
- Earlier in Dec 2023, the company submitted a BLA to the US FDA for Linvoseltamab, a bispecific Ab that integrates BCMA (on multiple myeloma cells) with CD3-expressing T cells causing T-cell activation & cancer-cell killing
Ref: Regeneron | Image: Regeneron
Related News:- Regeneron to Present Updated Results of Linvoseltamab for Patients with Heavily Pre-treated Multiple Myeloma at ASCO 2023
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Shivani is a content writer at PharmaShots. She has a keen interest in recent innovations in the life sciences industry. She covers news related to Product approvals, clinical trial results, and updates. She can be contacted at connect@pharmashots.com.
