2024 OCE Annual Report
Center Director's Message
In 2024, the Oncology Center of Excellence facilitated 49 oncology drug and biologic product approvals. This total included 18 new medical entities or new biological license applications and 31 new indications for previously approved products. Additionally, 10 products were approved under the 505(b)(2) pathway or as biosimilars and 76 oncology devices were authorized.
Among these significant achievements, eight different drugs and biologics were approved to treat pediatric patients with cancer and several others were approved for adults with rare cancers. Visit the Regulatory Review and Regulatory Programs pages of this report for further details on 2024 oncology approvals.
OCE’s regulatory and clinical programs and projects continued to advance in support of our mission. Some highlights:
- Project Orbis, in its fifth year, collaborated with international regulatory partners on 23 product approvals that included 5 new products and 18 indication extensions.
- The Rare Cancers Program took part in outreach activities including support for a CURE ID project aimed at capturing the real-world experience of patients with rare cancers.
- The Precision Oncology Program led the FDA’s publication of a final guidance on Circulating Tumor DNA for Curative-Intent Solid Tumor Drug Development, a landmark document that standardizes the use of this biomarker.
- Project Facilitate managed 364 phone inquiries and processed 761 single-patient Expanded Access applications allowing patients with cancer to try investigational medical products when no satisfactory therapies are available and there is no opportunity for the patient to enroll in a clinical trial.
Please explore our 2024 Annual Report to learn more about the OCE’s work to improve the lives of patients with cancer.
Richard Pazdur, M.D.
Director, Oncology Center of Excellence