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P56: Performance of Project Orbis and the Real Time Oncology Review (RTOR) Pilot Program

Poster Presenter

Kim Olsen

Associate Director, Global Regulatory Policy and Intelligence, Global Regulatory
Janssen Research and Development
United States

Objectives

This research compares FDA review times for approvals utilizing two pilots available through the FDA Oncology Center of Excellence (Project Orbis & RTOR) to approvals that did not utilize these pilots during the same time period.

Method

Oncology approvals were identified on the Hematology/Oncology Approvals & Safety Notifications webpage. Additional information was collected from OCE annual reports and Drugs@FDA. Review times were calculated from final application submission (date on approval letter) to approval date.

Results

Project Orbis was launched in May 2019 and since that time has approved 22 applications (some as combinations) with five of those as NMEs. The first Project Orbis approval took place on September 17, 2019, in conjunction with the Australian Therapeutic Goods Administration and Health Canada with approval of the combination of Lenvatinib and pembrolizumab for patients with advanced endometrial carcinoma. The first NME approved under ORBIS was tucatinib, approved in April 2020 in combination with trastuzumab and capecitabine, for patients with advanced unresectable or metastatic HER2-positive breast cancer. The RTOR pilot program was launched in February 2018. The first approval under RTOR was a supplement for ribociclib, an expanded indication for breast cancer, in July 2018. The first NME approval under RTOR was alpelisib, also approved for breast cancer, in July 2018. Since February 2018 (and through February 2021), there have been 188 applications approved by OCE. Approvals include separate applications for combination regimens and drugs approved for two indications. During this time, 39 applications used either Project Orbis, RTOR or both. The average review time for these was 3.9 months. The average review time for applications not using Project Orbis or RTOR was 4.75 months. The average review time for applications using Project Orbis (with or without RTOR, N=22) was 3.9 months. The average review time for applications using RTOR (with or without Project Orbis, N=35) was 3.7 months.

Conclusion

The FDA OCE, working with centers and offices across the FDA, expedites the development of oncology and hematology medical products by supporting an integrated approach in the clinical evaluation of drugs, biologics, and devices for the treatment of cancer. Two resources available to the pharmaceutical industry through the OCE include the Real-Time Oncology Review and Project Orbis. Project Orbis provides the framework for concurrent submission and review of oncology drugs among international partners. The RTOR pilot program aims to explore a more efficient review process by allowing the FDA to review much of the data earlier, before the applicant formally submits the complete application resulting in shorter review times. The use of resources available through the OCE expedites the review process for oncology and hematology medical products.