FDA serves up a quick rejection of China-only data with a CRL for Lilly's PD-1
The FDA sent over a quick rejection letter on Thursday to Eli Lilly regarding its anti-PD-1 antibody sintilimab, further crushing the hopes of any companies looking to bring cheaper follow-ons based only on Chinese data.
The complete response letter (CRL) follows a nearly unanimous Oncologic Drugs Advisory Committee (ODAC) recommendation against sintilimab’s approval, which was intended as a first-line treatment for people with nonsquamous non-small cell lung cancer. The FDA also revealed at the meeting that the company submitted the application without consulting regulators before the trial concluded, and misrepresented interactions with the agency during its presentation.
Unlock this article instantly by becoming a free subscriber.
You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.