The US Food and Drug Administration has started conducting collaborative reviews with foreign regulators under a new initiative that could help streamline global clinical trials while also speeding the approval of supplemental indications for cancer drugs in smaller countries.
On 17 September, the FDA’s Oncology Center of Excellence (OCE) announced the launch of Project Orbis, a collaboration that provides a framework for concurrent submission and review of
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Treatment of patients with advanced endometrial carcinoma that is not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), and who have disease progression following prior