US Food and Drug Administration Approval of New Drugs Based on Noninferiority Trials in Oncology: A Dangerous Precedent?

JAMA Oncol. 2019 May 1;5(5):607-608. doi: 10.1001/jamaoncol.2019.0093.

Authors

Bishal Gyawali¹, Aaron S Kesselheim¹

Affiliation

¹ Program on Regulation, Therapeutics, and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.

PMID: 30920591
DOI: 10.1001/jamaoncol.2019.0093

No abstract available

MeSH terms

Antineoplastic Agents / therapeutic use
Drug Approval*
Equivalence Trials as Topic*
Humans
Neoplasms / drug therapy
Phenylurea Compounds / therapeutic use
Quinolines / therapeutic use
Sorafenib / therapeutic use
United States
United States Food and Drug Administration

Substances

Antineoplastic Agents
Phenylurea Compounds
Quinolines
Sorafenib
lenvatinib