Regeneron Reports US FDA’s Acceptance of Resubmitted BLA for Linvoseltamab to Treat R/R Multiple Myeloma (MM)
Shots:
- The US FDA has accepted resubmitted BLA for linvoseltamab to treat r/r MM in pts who received ≥4L or ≥3L & were unresponsive to the last line (PDUFA: Jul 10, 2025) after resolving third-party fill/finish manufacturing issues; MAA is under EMA review
- Application was backed by P-I/II (LINKER-MM1) trial data, assessing linvoseltamab (200mg) in pts (n=282), where ongoing P-II dose expansion portion is evaluating ORR (1EP) with 2EPs of DoR, PFS, OS & min. residual disease negative status 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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