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Accelerated approval

Accelerated approval is an FDA pathway that allows faster approval of drugs for serious conditions that fill an unmet medical need[1]. The faster approval relies on the use of surrogate endpoints[1].

A surrogate endpoint is a laboratory measurement or a physical sign used as a substitute for a clinically meaningful endpoint that measures directly how a patient feels, functions or survives[2]. It may correlate with a real clinical endpoint but does not necessarily have a guaranteed relationship to it[3]. The FDA started its Accelerated Approval Program in 1992[1].

Drugs approved under the programme still need to be tested in clinical trials using endpoints that demonstrate clinical benefit, and these trials are known as phase 4 confirmatory trials[4]. If the drug later proves unable to demonstrate clinical benefit to patients, the FDA may withdraw approval[4].

Zanidatamab is one example, as it was first granted accelerated approval for medical use in the United States on 21 November 2024[5].

Why it matters to investors

A surrogate endpoint may correlate with a real clinical endpoint but does not necessarily have a guaranteed relationship with it[3]. After accelerated approval, the FDA may withdraw approval if the drug later proves unable to demonstrate clinical benefit to patients[4].

Related: Phase 4 (post-marketing), Priority review, Breakthrough therapy designation

Sources

  1. "Accelerated Approval Program" . NDA and BLA Approvals . United States Food and Drug Administration . 1 December 2022. Archived from the original on December 2, 2022 . Retrieved 28 January 2023 . web.archive.org (via Wikipedia: Accelerated approval (FDA))
  2. Temple RJ. A regulatory authority's opinion about surrogate endpoints. Clinical Measurement in Drug Evaluation. Edited by Nimmo WS, Tucker GT. New York: Wiley; 1995. (via Wikipedia: Surrogate endpoint)
  3. De Gruttola, Victor G; Clax, Pamela; DeMets, David L ; Downing, Gregory J; Ellenberg, Susan S; Friedman, Lawrence; Gail, Mitchell H; Prentice, Ross ; Wittes, Janet ; Zeger, Scott L (2001). "Considerations in the Evaluation of Surrogate Endpoints in Clinical Trials". Controlled Clinical Trials . 22 (5): 485– 502. doi : 10.1016/S0197-2456(01)00153-2 . ISSN 0197-2456 . PMID 11578783 . doi.org; Cohn JN (2004). "Introduction to Surrogate Markers" . Circulation . 109 (25 Suppl 1): IV20–1. doi : 10.1161/01.CIR.0000133441.05780.1d . PMID 15226247 . doi.org (via Wikipedia: Surrogate endpoint)
  4. "Accelerated Approval Program" . NDA and BLA Approvals . United States Food and Drug Administration . 1 December 2022. Archived from the original on December 2, 2022 . Retrieved 28 January 2023 . web.archive.org; "Food and Drug Administration: Patient Advocates" . Food and Drug Administration . 26 June 2013. Archived from the original on 22 September 2013 . Retrieved 6 August 2013 . web.archive.org (via Wikipedia: Accelerated approval (FDA))
  5. "FDA grants accelerated approval to zanidatamab-hrii for previously treated unresectable or metastatic HER2-positive biliary tract cancer" . U.S. Food and Drug Administration (FDA) . 21 November 2024. Archived from the original on 21 November 2024 . Retrieved 23 November 2024 . This article incorporates text from this source, which is in the public domain . fda.gov; "Cancer Accelerated Approvals" . U.S. Food and Drug Administration (FDA) . 1 October 2024. Archived from the original on 27 October 2021 . Retrieved 6 December 2024 . fda.gov (via Wikipedia: Zanidatamab)

Checked 8 October 2026. How we check sources