Table 1 Comparison of oncology drug/indication combinations approved by Food and Drug Administration and Health Canada requiring Canada
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Atezolizumab | Urothelial cancer, second line | 2016-05-18 | Voluntarily withdrawn | 2021-04-13 | 2017-04-12 | None | NOC not fulfilled as of 2021-09-11 | Could not be determined |
Bevacizumab | Glioblastoma | 2009-05-05 | Converted to regular approval | 2017-12-05 | 2010-03-24 | Indication withdrawn, no reason given | 2018-05-23 | Different |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Durvalumab | Urothelial cancer | 2017-05-01 | Voluntarily withdrawn | 2021-02-19 | 2017-11-03 | None | NOC not fulfilled as of 2021-09-11 | Could not be determined |
Gefitinib | Non-small cell lung cancer | 2003-05-05 | Voluntarily withdrawn; subsequently approved in different population (EGFR mutations positive only) | 2005-06-17 | 2003-12-17 | Converted to regular approval for patients who have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Nivolumab | Hepatocellular cancer | 2017-09-22 | Voluntarily withdrawn | 2021-07-23 | 2018-03-23 | None | NOC not fulfilled as of 2021-09-11 | Could not be determined |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Olaratumab | Soft tissue sarcoma | 2016-10-19 | Voluntarily withdrawn | 2019-04-26 | 2017-11-23 | Discontinued by company | 2020-10-08 | Similar |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 |