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Regeneron’s Lynozyfic (Linvoseltamab-gcpt) Receives the US FDA’s Accelerated Approval for R/R Multiple Myeloma

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  • The US FDA has granted accelerated approval to Lynozyfic for the treatment of r/r MM pts, who have received ≥4L therapy, incl. a proteasome inhibitor, an immunomodulatory agent & an anti CD38 mAb based on P-I/II (LINKER-MM1) trial in >300 pts; a SC P-I trial portion & IV P-II dose expansion portion is ongoing
  • In the trial, 80 pts showed a 70% ORR & 45% CR rate per IRC, with a median time to first response of 0.95mos.; mDOR was unreached, & estimated DoR at 9 & 12mos. was 89% & 72%, respectively, among responders with mFU of 13mos. 
  • Additionally, Lynozyfic 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 | Press Release

Related News:- Regeneron’s Lynozyfic (Linvoseltamab) Receives the EC’s Conditional Approval for R/R Multiple Myeloma

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