CStone Reports NMPA Acceptance of sNDA and Granted Priority Review for Sugemalimab to treat Relapsed or Refractory Extranodal Natural Killer/T-Cell Lymphoma
Shots:
- The NMPA has accepted the sNDA and granted priority review to sugemalimab for the treatment of r/r ENKTL
- The sNDA was based on the P-II (GEMSTONE-201) study to evaluate the efficacy and safety of sugemalimab as monothx. in adult patients with r/r ENKTL. The results showed an improved ORR over historical controls, ORR was 46.2% as assessed by IRRC in 78 evaluable patients with a CR rate of 37.2%, investigator-assessed ORR was highly consistent with IRRC’s evaluation
- In the subgroup analyses, sugemalimab is expected to be effective in a variety of ENKTL & has a well-tolerated safety profile with no new safety signal. Sugemalimab has received the BTD from the US FDA and NMPA for r/r ENKTL
Ref: CStone | Image: CStone
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