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Table 1 Comparison of oncology drug/indication combinations approved by Food and Drug Administration and Health Canada requiring Canada

From: A comparison of the Food and Drug Administration’s and Health Canada’s regulatory decisions about failed confirmatory trials for oncology drugs: an observational study

Generic name Approved indication Food and Drug Administration Health Canada Comparison of decisions
Date of marketing approval Decision about drug/indication Date of decision about drug/indication Date of marketing approval Decision about drug/indication Date of decision about drug/ indication
Atezolizumab PDL1 + triple negative breast cancer 2019-03-08 ODAC voted 7–2 against withdrawal Pending as of 2021-09-11 2019-08-21 None NOC/c not fulfilled as of 2021-09-11 Could not be determined
Atezolizumab Urothelial cancer, second line 2016-05-18 Voluntarily withdrawn 2021-04-13 2017-04-12 None NOC not fulfilled as of 2021-09-11 Could not be determined
Bevacizumab Glioblastoma 2009-05-05 Converted to regular approval 2017-12-05 2010-03-24 Indication withdrawn, no reason given 2018-05-23 Different
Bevacizumab HER2 negative breast cancer 2008-02-22 Revoked by FDA over objection of manufacturer 2011-12-20 2009-02-06 Indication suspended, no reason given 2011-12-25 Similar
Durvalumab Urothelial cancer 2017-05-01 Voluntarily withdrawn 2021-02-19 2017-11-03 None NOC not fulfilled as of 2021-09-11 Could not be determined
Gefitinib Non-small cell lung cancer 2003-05-05 Voluntarily withdrawn; subsequently approved in different population (EGFR mutations positive only) 2005-06-17 2003-12-17 Converted to regular approval for patients who have activating mutations of the EGFR-TK 2009-12-18 Similar
Nivolumab Hepatocellular cancer 2017-09-22 Voluntarily withdrawn 2021-07-23 2018-03-23 None NOC not fulfilled as of 2021-09-11 Could not be determined
Nivolumab Melanoma after ipilimumab or BRAF inhibitor 2014-12-22 Converted to regular approval on basis of results from other trials 2019-03-07 2016-04-29 Converted to regular approval 2018-02-21 Similar
Olaratumab Soft tissue sarcoma 2016-10-19 Voluntarily withdrawn 2019-04-26 2017-11-23 Discontinued by company 2020-10-08 Similar
Pembrolizumab Urothelial cancer, first line 2017-05-18 Converted to regular approval 2021-08-31 2019-04-11 None 2021-09-11 Could not be determined
  1. FDA  Food and Drug Administration, ODAC  Oncology Drug Advisory Committee
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Journal of Pharmaceutical Policy and Practice

ISSN: 2052-3211

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