Eli Lilly and Innovent Report the US FDA’s Acceptance of Sintilimab + Chemotherapy for 1L Treatment for Non-Squamous NSCLC

May 18, 2021 Auto Bot 1L, chemotherapy, Eli Lilly, FDA, Innovent, regulatory, Sintilimab 0

Shots:

  • The submission is based on a P-III ORIENT-11 study assessing sintilimab (200mg) + pemetrexed and platinum CT vs PBO + CT as a 1L treatment for 397 patients in a ratio (2:1) with advanced or metastatic nonsq. NSCLC, with no sensitizing EGFR mutations or ALK rearrangements
  • The anticipated PDUFA date for this application is in Mar’2021
  • Sintilimab is currently being evaluated across multiple cancer indications. Sintilimab has two indications approved in China, three regulatory submissions under review in China, and this regulatory application under review in the US

Click here to­ read full press release/ article | Ref: PRNewswire | Image: Lixoft

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