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Sunday, June 2, 2024

'ASCO 2024: FDA oncology head wants clinical trials to range beyond China alone'

 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.

https://www.statnews.com/2024/06/01/asco-fda-oncology-cancer-pazdur-trials-china/

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