Withdrawn accelerated approvals for cancer indications in the USA: what is the marketing authorisation status in the EU?
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Withdrawn accelerated approvals for cancer indications in the USA : what is the marketing authorisation status in the EU? / Cramer, Allan; Sørup, Freja K H; Christensen, Hanne R; Petersen, Tonny S; Karstoft, Kristian.
In: The Lancet. Oncology, Vol. 24, No. 9, 2023, p. e385-e394.Research output: Contribution to journal › Review › Research › peer-review
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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T1 - Withdrawn accelerated approvals for cancer indications in the USA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accelerated approvals for cancer indications granted by the US Food and Drug Administration (FDA) since 1992 have been withdrawn from the US market, with 17 (74%) of 23 withdrawn in the past 3 years.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the European Medicines Agency (EMA) was done to investigate whether the accelerated approvals for cancer indications withdrawn by the FDA have a marketing authorisation in the EU to date, and to compare the approval history of these indications by the EMA and FDA. We found that, as of April 20, 2023, nine (39%) of 23 withdrawn accelerated approvals for cancer indications in the USA have a marketing authorisation in the EU for a similar indication. By comparison, only two conditional marketing authorisations for cancer indications have been withdrawn from the EU; both are no longer approved in the USA.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accelerated approvals for cancer indications granted by the US Food and Drug Administration (FDA) since 1992 have been withdrawn from the US market, with 17 (74%) of 23 withdrawn in the past 3 years.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 -
ID: 387071640