FDA Oncology Chief Denies Claims that Rejection of Lilly and Innovent Cancer Drug is Politically Motivated

March 29, 2022

On the heels of the FDA’s rejection of Eli Lilly and Innovent Biologics’ low-cost lung cancer immunotherapy drug sintilimab, the agency’s oncology chief, Richard Pazdur, MD, argues that the rejection is not due to rising geopolitical tensions. Instead, he argues, “It’s in the long-term interests of all countries” to conduct international multiregional trials unlike those for sintilimab, which were only performed in China, Innovent Biologic’s home country.

According to Angus Liu of Fierce Pharma, “The FDA is still getting familiar with clinical trial sites in China. As Pazdur noted, the FDA has limited inspection capabilities of clinical sites. When the FDA encounters a trial with data from one country or sites that the agency isn’t familiar with, it usually turns to international data from various sites to gain assurance, Pazdur explained, calling the practice ‘an experiential type of thing that is developed over years.’ But with sintilimab, approved in China under the brand name Tyvyt, that cross-reference wasn’t an option.”

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