As expected, the US Food and Drug Administration has issued a complete response letter (CRL) for the investigational checkpoint blocker sintilimab.
Developed by Eli Lilly (NYSE: LLY) in collaboration with Chinese firm Innovent Biologics (HKEX: 01801), the biologic is being proposed as an option for people with lung cancer.
The firm’s submission was designed to support approval for use of the product, in combination with pemetrexed and platinum chemotherapy, for the first-line treatment of people with non-squamous non-small cell lung cancer (NSCLC).
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