Comparing supplemental indications for cancer drugs approved in the US and EU

Author:

Stoelinga Jelle,Bloem Lourens T.,Russo Massimiliano,Kesselheim Aaron S.,Feldman William B.

Funder

Arnold Ventures

National Heart, Lung, and Blood Institute

Publisher

Elsevier BV

Reference43 articles.

1. T. Addressing the challenge of high-priced prescription drugs in the era of precision medicine: A systematic review of drug life cycles, therapeutic drug markets and regulatory frameworks;Gronde;PLoS One,2017

2. Trends in the approval of cancer therapies by the FDA in the twenty-first century;Scott;Nat Rev Drug Discov,2023

3. United States Food and Drug Administration. Accelerated Approval. Published February 2, 2023. Accessed May 23, 2024. 〈https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/accelerated-approval〉

4. European Medicines Agency. Conditional Marketing Authorisation. Published 2024. Accessed May 23, 2024. 〈https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/conditional-marketing-authorisation〉

5. Accelerated approval is not conditional approval: Insights from international expedited approval programs;Mehta;JAMA Oncol,2022

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