LLY Eli Lilly and Co

By Colin Kellaher

Innovent Biologics Inc. and Eli Lilly & Co. on Tuesday said the U.S. Food and Drug Administration accepted for review a biologics license application for sintilimab injection in combination with pemetrexed and platinum chemotherapy for the first-line treatment of nonsquamous non-small cell lung cancer.

The companies said the FDA didn't identify any potential review issues and isn't currently planning to hold an advisory committee meeting to discuss the application, adding that the agency set a target action date in March 2022.

Indianapolis drugmaker Eli Lilly and Innovent, a Suzhou, China, pharmaceutical company, have been collaborating since March 2015. The filing marks the first U.S. regulatory submission of sintilimab, which the companies jointly developed and is marketed as Tyvyt in China.

Write to Colin Kellaher at colin.kellaher@wsj.com

(END) Dow Jones Newswires

May 18, 2021 06:42 ET (10:42 GMT)

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