Regulatory Fate of Cancer Indications in the European Union After Accelerated Approval in the US

Tonny Studsgaard Petersen; Kristian Karstoft; Freja Karuna Hemmingsen Sørup; Marie Lund; Allan Cramer

doi:10.1001/jamaoncol.2024.5145

Regulatory Fate of Cancer Indications in the European Union After Accelerated Approval in the US

JAMA Oncol. 2025 Jan 1;11(1):70-71. doi: 10.1001/jamaoncol.2024.5145.

Authors

Tonny Studsgaard Petersen^{1

2}, Kristian Karstoft^{1

2}, Freja Karuna Hemmingsen Sørup^{1

2}, Marie Lund^{1

2

3}, Allan Cramer¹

Affiliations

¹ Department of Clinical Pharmacology, Copenhagen University Hospital-Bispebjerg and Frederiksberg, Copenhagen, Denmark.
² Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.
³ Department of Epidemiology Research, Statens Serum Institut, Copenhagen, Denmark.

PMID: 39541204
PMCID: PMC11565369 (available on 2025-11-14)
DOI: 10.1001/jamaoncol.2024.5145

No abstract available

Plain language summary

This cohort study investigates the regulatory fate in the European Union for drugs that received accelerated approval for cancer indications in the US.