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# 38 Project Orbis Approvals in First Full Year
- URL: https://www.fdaweb.com/38-project-orbis-approvals-in-first-full-year/
- Published: 2020-12-08T12:00:00.000Z
- Updated: 2026-09-14T16:39:16.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5148254

From 6/2019 to 6/2020, the first full year of the FDA Oncology Center of Excellence’s Project Orbis, the effort received 60 oncology marketing applications for either new molecular entities or supplements adding new indications. Of the 60, 38 were approved.

Project Orbis is intended to facilitate oncology product submissions in other countries without slowing regulatory action in the U.S. An *FDA Voices* online [post](https://www.fda.gov/news-events/fda-voices/project-orbis-strengthening-international-collaboration-oncology-product-reviews-faster-patient?utm%5Fmedium=email&utm%5Fsource=govdelivery) says six regulatory authorities are participating in the project, representing Australia, Canada, Singapore, Switzerland, Brazil, and the UK.

The post says that new molecular entities comprised 28% of the marketing applications received. Major oncology disease categories were represented in the submissions, with the most common indications in non-small cell lung cancer (10 application submissions), followed by chronic lymphocytic leukemia (10), acute myeloid leukemia (6), endometrial cancer (6), breast cancer (5), and hepatocellular cancer (5).