Cancer Drugs Approved on the Basis of a Surrogate End Point and Subsequent Overall Survival: An Analysis of 5 Years of US Food and Drug Administration Approvals

Affiliations

¹ Medical Oncology Service, National Cancer Institute, National Institutes of Health, Bethesda, Maryland.
² Division of Hematology and Medical Oncology, Knight Cancer Center, Oregon Health and Sciences University, Portland.

Chul Kim et al. JAMA Intern Med. 2015 Dec.

. 2015 Dec;175(12):1992-4.

doi: 10.1001/jamainternmed.2015.5868.

¹ Medical Oncology Service, National Cancer Institute, National Institutes of Health, Bethesda, Maryland.
² Division of Hematology and Medical Oncology, Knight Cancer Center, Oregon Health and Sciences University, Portland.

No abstract available

Comment in

Balancing Accelerated Approval for Drugs With Accelerated Withdrawal.
Braillon A, Menkes DB. Braillon A, et al. JAMA Intern Med. 2016 Apr;176(4):566-7. doi: 10.1001/jamainternmed.2016.0351. JAMA Intern Med. 2016. PMID: 27043114 No abstract available.
Balancing Accelerated Approval for Drugs With Accelerated Withdrawal--Reply.
Kim C, Prasad V. Kim C, et al. JAMA Intern Med. 2016 Apr;176(4):567. doi: 10.1001/jamainternmed.2016.0374. JAMA Intern Med. 2016. PMID: 27043117 No abstract available.
Demand cancer drugs that truly help patients.
Aggarwal A. Aggarwal A. Nature. 2018 Apr;556(7700):151. doi: 10.1038/d41586-018-04154-9. Nature. 2018. PMID: 29636577 No abstract available.