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Project Orbis

Meaning

Project Orbis is a collaborative program led by the U.S. Food and Drug Administration’s Oncology Center of Excellence, which provides a framework for the concurrent submission and review of promising cancer drug applications among international regulatory partners. Although its focus is oncology, this initiative significantly impacts the hormonal health domain by accelerating the global approval of new hormonal therapies and antagonists used in the treatment of hormone-sensitive cancers, such as breast and prostate cancer. This cooperation aims to provide earlier access to innovative treatments for patients worldwide.