FDA approval standards for anticancer agents - lessons from two recent approvals in breast cancer

Nat Rev Clin Oncol. 2021 Jul;18(7):397-398. doi: 10.1038/s41571-021-00504-1.

Authors

Bishal Gyawali^{1

2}, Aaron S Kesselheim³

Affiliations

¹ Program on Regulation, Therapeutics and Law (PORTAL), Brigham and Women's Hospital, Harvard Medical School, Boston, USA. bg.bishalgyawali@gmail.com.
² Department of Oncology, Department of Public Health Sciences and Division of Cancer Care and Epidemiology, Queen's University, Kingston, Canada. bg.bishalgyawali@gmail.com.
³ Program on Regulation, Therapeutics and Law (PORTAL), Brigham and Women's Hospital, Harvard Medical School, Boston, USA.

PMID: 33767454
DOI: 10.1038/s41571-021-00504-1

No abstract available

Publication types

Research Support, Non-U.S. Gov't

MeSH terms

Antibodies, Monoclonal / therapeutic use
Antineoplastic Agents / standards
Antineoplastic Agents / therapeutic use*
Bias
Biomarkers, Tumor / analysis
Biomarkers, Tumor / physiology
Breast Neoplasms / drug therapy
Breast Neoplasms / mortality
Breast Neoplasms / pathology
Clinical Trials as Topic / standards
Clinical Trials as Topic / statistics & numerical data
Drug Approval* / methods
Drug-Related Side Effects and Adverse Reactions / epidemiology
Female
Humans
Neoplasm Metastasis
Quinolines / therapeutic use
Survival Analysis
United States / epidemiology
United States Food and Drug Administration / standards*

Substances

Antibodies, Monoclonal
Antineoplastic Agents
Biomarkers, Tumor
Quinolines
neratinib
margetuximab