FDA’s international drug review pilot could simplify cancer trials, get drugs to patients faster

FDA’s new joint international oncology drug review process could help companies and patients

FDA believes its new framework for the submission and review of cancer drugs concurrently in multiple countries will speed up patient access to new therapies and streamline drug development. The agency unveiled the framework, dubbed Project ORBIS, on Tuesday as it announced the first drug to be approved via the process, a combination regimen of Keytruda and Lenvima to treat endometrial cancer.

ORBIS is intended to allow patients in other countries to gain earlier access to therapies where there may be significant delays in regulatory submissions regardless of whether the product has received FDA approval.

“It’s the right thing to do. We as physicians should be interested in having the best quality of

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