hapabapa The head of the FDA's unit overseeing cancer therapies reaffirmed the agency's stance on drug approvals on Friday, noting that marketing applications based on international clinical studies are preferred over those focused on single-country trials. Richard Pazdur, the director of the FDA's oncology division, made the remarks a day after Florida-based Summit Therapeutics ( SMMT ) said its lead asset became the first lung cancer drug to outperform Merck's ( MRK ) blockbuster therapy Keytruda, albeit in a China- based late-stage trial. "I'm pro-multi-regional trials," Pazdur noted in an interview with Stat News at the 2024 American Society of Clinical Oncology in Chicago, IL.
His comments are not without precedent, as the FDA has previously rejected drugs sent for its approval based on single-country data. In 2022, the agency declined to approve Tyvyt (sintilimab), a lung cancer therapy developed by Eli Lilly ( LLY ) and Innovent Biologics ( OTCPK:IVBIY ) ( OTCPK:IVBXF ), as the companies had used data from a China-only trial to back their marketing application. More on etc.
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