comprehensive
CHICAGO — The Food and Drug Administration’s top oncologist reiterated that the agency doesn’t want drugmakers applying for approval with data from trials solely run in a single country such as China, but instead wants to see companies conducting studies across the world.
The comments by Richard Pazdur, director of the FDA’s Oncology Center of Excellence, came as more drugmakers report data from China, with Miami-based Summit Therapeutics earlier this week announcing that its investigational drug beat Merck’s blockbuster Keytruda in a head-to-head non-small cell lung cancer study in China.
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It’s not a blanket policy, and the agency would assess each company’s submission to see how applicable the data are to the U.S. population, but in general, “I am pro multi-regional trials,” Pazdur said Friday at STAT@ASCO, STAT’s event at the American Society of Clinical Oncology annual meeting.
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