Shots:
- The EC has granted conditional approval to Lynozyfic for the treatment of adults with r/r multiple myeloma based on P-I/II (LINKER-MM1) trial data assessing Lynozyfic in >300 pts; P-II dose expansion portion is ongoing. BLA under the US FDA’s Review (PDUFA: Jul 10, 2025)
- In the trial, 117 pts on 200mg had a 71% ORR, with 50% CR rate per IRC, where CR or stringent CR pts showed MRD negativity rate of 41%; trial showed mDOR of 29mos.
- 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
Related News:- Regeneron and Sanofi Report the US FDA’s Approval of Dupixent for Chronic Spontaneous Urticaria
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