The CHMP Recommends Conditional Approval of Regeneron’s Linvoseltamab to Treat R/R Multiple Myeloma (MM)
Shots:
- The CHMP has recommended conditional approval of linvoseltamab for r/r MM pts who had ≥3 prior therapies (incl. proteasome inhibitor, immunomodulator, & anti-CD38 mAb) & had disease progression on last therapy, following the US FDA’s BLA acceptance (PDUFA: Jul 10, 2025)
- Opinion was based on P-I/II (LINKER-MM1) trial data assessing linvoseltamab (200mg; QW then Q2W at 16wks. followed by Q4W if pts achieved VGPR or better at ≥24wks.) in 282 pts. Ongoing P-II dose expansion portion is evaluating ORR (1EP), with 2EPs of DoR, PFS, OS & MRD negativite rate
- Also, Linvoseltamab is being studied in P-III (LINKER-MM3) trial as a monotx. & P-Ib (LINKER-MM2) trial to treat r/r MM in combination with other cancer treatments
Ref: Regeneron | Image: Regeneron
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