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# FDA Looking to Expand Project Orbis Outside Oncology
- URL: https://www.fdaweb.com/fda-looking-to-expand-project-orbis-outside-oncology/
- Published: 2025-07-17T12:00:00.000Z
- Updated: 2026-09-14T15:16:49.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159530

FDA Oncology Center of Excellence (OCE) director **Richard Pazdur** says the agency and its international partners are considering expanding Project Orbis from exclusively oncology products to other therapeutic areas. Project Orbis is a collaborative program led by OCE that facilitates the concurrent submission and review of oncology products among international regulatory partners. It aims to expedite the availability of new cancer treatments to patients globally by streamlining the regulatory process.

“What we have done in oncology could serve as a framework for other therapeutic areas,” Pazdur said in an [internal interview](https://www.fda.gov/international-programs/global-perspective/reflections-25-years-global-oncology?ref=fdaweb.com) posted on FDA’s Web site. “Agencies have requested that we consider expanding Orbis to other disease areas. We have an oncology-specific expertise that facilitates the review of complex applications. For example, we have teams that deal exclusively with breast cancer, teams for lung cancer, teams for head and neck cancer, multiple myeloma teams, sarcoma teams and pediatric experts. We are sub-specialized, reflecting the structure of many university and cancer center programs. Oncology changes so rapidly that teams need expertise in the selected oncology diseases. Outside of the United States, smaller agencies do not have this internal expertise. Project Orbis enables these agencies to confer with FDA regulators who have disease-specific knowledge.”

Asked about clinical trials in the U.S., Pazdur said FDA is vigorously promoting drug development in the U.S. “The U.S. is the largest market for oncology drugs, and we think there needs to be a push to get more patients into trials in the United States and to explore and address these challenges. We have a project in OCE called Project Site Selector. Drug regulators have traditionally not thoroughly queried companies prior to the trial initiation on methods to select sites and the generalizability of the data collected from these sites to the U.S. population and medical practice.”