Logo

CStone Reports NMPA Acceptance of sNDA and Granted Priority Review for Sugemalimab to treat Relapsed or Refractory Extranodal Natural Killer/T-Cell Lymphoma

Share this
CStone Reports NMPA Acceptance of sNDA and Granted Priority Review for Sugemalimab to treat Relapsed or Refractory Extranodal Natural Killer/T-Cell Lymphoma

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 

Click here to­ read the full press release 

Neha

Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

Share this article on WhatsApp, LinkedIn and Twitter

Join the PharmaShots family of 12000+ subscribers

I accept the Terms and Conditions