Medicare Expenditures of Atezolizumab for a Withdrawn Accelerated Approved Indication

Author:

Ballreich Jeromie12,Bennet Charles34,Moore Thomas J.25,Alexander G. Caleb1267

Affiliation:

1. Department of Health Policy & Management, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland

2. Center for Drug Safety and Effectiveness, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland

3. The University of South Carolina College of Pharmacy, Columbia

4. The Center for Comparative Effectiveness, The City of Hope Comprehensive Cancer Center, Duarte, California

5. Department of Epidemiology, Milken Institute School of Public Health, George Washington University, Washington, DC

6. Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland

7. Division of General Internal Medicine, Johns Hopkins Medicine, Baltimore, Maryland

Publisher

American Medical Association (AMA)

Subject

Oncology,Cancer Research

Reference6 articles.

1. Assessment of the clinical benefit of cancer drugs receiving accelerated approval.;Gyawali;JAMA Intern Med,2019

2. Atezolizumab versus chemotherapy in patients with platinum-treated locally advanced or metastatic urothelial carcinoma (IMvigor211): a multicentre, open-label, phase 3 randomised controlled trial.;Powles;Lancet,2018

3. US Food and Drug Administration. CFR—Code of Federal Regulations Title 21. Accessed March 16, 2021. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=1.4

4. US Food and Drug Administration. FDA Oncologic Drugs Advisory Committee to review status of six indications granted accelerated approval. Accessed March 16, 2021. https://www.fda.gov/news-events/fda-brief/fda-brief-fda-oncologic-drugs-advisory-committee-review-status-six-indications-granted-accelerated

5. US Food and Drug Administration. Authors’ analysis of the FDA's CDER Accelerated Approvals database. Accessed June 16, 2021. https://www.fda.gov/drugs/nda-and-bla-approvals/accelerated-approvals

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