FDA Advisory Committee requires additional trials for Tyvyt to show applicability to USA for NSCLC.
The FDA’s Oncologic Drug Advisory Committee (ODAC) voted 14 to 1 that the FDA should require additional clinical trial(s) demonstrating applicability to patients in the United States (US) and US medical care before making a regulatory decision on the biologics license application (BLA) for sintilimab (Tyvyt) injection in combination with pemetrexed and platinum chemotherapy for the first-line treatment of patients with nonsquamous non–small cell lung cancer (NSCLC).
A biologics license application (BLA) was submitted to the FDA for this indication on May 18, 2021. The application is supported by findings from the phase III ORIENT-11 clinical trial (NCT03607539). In the study, treatment with sintilimab led to improved survival and responses in patients with locally advanced or metastatic nonsquamous NSCLC. Committee members agreed that the companies did not enroll a diverse enough population in their trial, which took place only at hospitals in China, for results to be applicable to U.S. patients.
"Single-country trials are a step backward," said Richard Pazdur, the FDA's top cancer drug regulator, who has in recent months raised concerns about approving in the U.S. medicines that were developed exclusively in China.
Specifically, the FDA did not believe ORIENT-11 is applicable to U.S. lung cancer patients because too many of the study's participants were non-smokers, men and on average younger than is typical in the U.S. As the study was conducted only at Chinese medical centers, no volunteers were white, black or hispanic ethnicity.
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