Innovent and Eli Lilly jointly announced that the U.S. Food and Drug Administration (FDA) accepted for review a Biologics License Application (BLA) for sintilimab injection in combination with pemetrexed and platinum chemotherapy for the first-line treatment of people with nonsquamous non-small cell lung cancer (NSCLC). This is the first U.S. regulatory submission for sintilimab, a PD-1 inhibitor being developed and commercialized under a global collaboration agreement between Innovent and Lilly.
"The acceptance of this application – the first for sintilimab in the U.S. and outside of China – is an important milestone in Innovent's global commercialization strategy and in our collaboration with Lilly," said Dr. Yongjun Liu, president of Innovent. "We look forward to working closely with the FDA to potentially bring this sintilimab-pemetrexed-platinum chemotherapy combination as a treatment option in the U.S., following the regimen's regulatory approval in China earlier this year."
The BLA was submitted to the FDA in March 2021, primarily based on the results of the Phase 3 ORIENT-11 trial. The Prescription Drug User Fee Act (PDUFA) goal date for...
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