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Innovent and Lilly Receive the NMPA’s Approval for Tyvyt (sintilimab) sNDA as 1L Treatment for Esophageal Squamous Cell Carcinoma

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Innovent and Lilly Receive the NMPA’s Approval for Tyvyt (sintilimab) sNDA as 1L Treatment for Esophageal Squamous Cell Carcinoma

Innovent and Lilly Receive the NMPA’s Approval for Tyvyt (sintilimab) sNDA as 1L Treatment for Esophageal Squamous Cell Carcinoma

Shots:

  • The NMPA has approved sNDA for Tyvyt in combination with cisplatin + paclitaxel or cisplatin + 5-fluorouracil CT for unresectable, LA, recurrent or m-ESCC regardless of PD-L1 expression status
  • The approval was based on the interim analysis of the P-III (ORIENT-15) trial evaluating sintilimab + CT vs PBO + CT in a ratio (1:1) in 659 patients which showed an improvement in OS & PFS with m-OS (16.7mos. vs 12.5mos.) & m-PFS (7.2mos. vs 5.7mos.) thus meeting the pre-defined efficacy criteria. The safety profile was consistent with prior reported studies of sintilimab without new or unexpected safety signals
  • The therapy was approved in China for r/r CHL & other indications. Lilly will provide high-quality, affordable drugs & effective treatment options to Chinese patients

Ref: PRNewswire | Image: Innovent

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.

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