TY - JOUR

T1 - Withdrawn accelerated approvals for cancer indications in the USA

T2 - what is the marketing authorisation status in the EU?

AU - Cramer, Allan

AU - Sørup, Freja K H

AU - Christensen, Hanne R

AU - Petersen, Tonny S

AU - Karstoft, Kristian

N1 - Copyright © 2023 Elsevier Ltd. All rights reserved.

PY - 2023

Y1 - 2023

N2 - As of April, 2023, 23 accelerated approvals for cancer indications granted by the US Food and Drug Administration (FDA) since 1992 have been withdrawn from the US market, with 17 (74%) of 23 withdrawn in the past 3 years. The marketing authorisation status of these indications in the EU has not been reported. A review of relevant documents from the FDA and the European Medicines Agency (EMA) was done to investigate whether the accelerated approvals for cancer indications withdrawn by the FDA have a marketing authorisation in the EU to date, and to compare the approval history of these indications by the EMA and FDA. We found that, as of April 20, 2023, nine (39%) of 23 withdrawn accelerated approvals for cancer indications in the USA have a marketing authorisation in the EU for a similar indication. By comparison, only two conditional marketing authorisations for cancer indications have been withdrawn from the EU; both are no longer approved in the USA. These findings indicate a discrepancy in the approval policies between the FDA and EMA and imply either that some patient groups in the USA do not get access to relevant medical treatment, or that some patient groups in the EU are treated with medicine without a positive benefit-risk balance. These discrepancies could potentially be reduced by increased collaboration and information sharing between the two agencies.

AB - As of April, 2023, 23 accelerated approvals for cancer indications granted by the US Food and Drug Administration (FDA) since 1992 have been withdrawn from the US market, with 17 (74%) of 23 withdrawn in the past 3 years. The marketing authorisation status of these indications in the EU has not been reported. A review of relevant documents from the FDA and the European Medicines Agency (EMA) was done to investigate whether the accelerated approvals for cancer indications withdrawn by the FDA have a marketing authorisation in the EU to date, and to compare the approval history of these indications by the EMA and FDA. We found that, as of April 20, 2023, nine (39%) of 23 withdrawn accelerated approvals for cancer indications in the USA have a marketing authorisation in the EU for a similar indication. By comparison, only two conditional marketing authorisations for cancer indications have been withdrawn from the EU; both are no longer approved in the USA. These findings indicate a discrepancy in the approval policies between the FDA and EMA and imply either that some patient groups in the USA do not get access to relevant medical treatment, or that some patient groups in the EU are treated with medicine without a positive benefit-risk balance. These discrepancies could potentially be reduced by increased collaboration and information sharing between the two agencies.

KW - United States

KW - Humans

KW - Neoplasms/drug therapy

KW - Information Dissemination

KW - Marketing

KW - Medicine

KW - United States Food and Drug Administration

U2 - 10.1016/S1470-2045(23)00357-1

DO - 10.1016/S1470-2045(23)00357-1

M3 - Review

C2 - 37657479

VL - 24

SP - e385-e394

JO - The Lancet Oncology

JF - The Lancet Oncology

SN - 1470-2045

IS - 9

ER -