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. 2021 Nov 1;7(11):1720-1721.
doi: 10.1001/jamaoncol.2021.4757.

Medicare Expenditures of Atezolizumab for a Withdrawn Accelerated Approved Indication

Jeromie Ballreich  1   2 , Charles Bennet  3   4 , Thomas J Moore  2   5 , G Caleb Alexander  1   2   6   7
Affiliations

Medicare Expenditures of Atezolizumab for a Withdrawn Accelerated Approved Indication

Jeromie Ballreich et al. JAMA Oncol. .

Abstract

This cross-sectional study examines atezolizumab as a second-line treatment for malignant urothelial carcinoma, which received accelerated US Food and Drug Administration approval, although the manufacturer’s confirmatory trial did not identify benefits.

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Conflict of interest statement

Conflict of Interest Disclosures: Drs Ballreich and Moore reported grants from Arnold Ventures during the conduct of the study. Dr Alexander reported being a past chair and current member of the US Food and Drug Administration’s Peripheral and Central Nervous System Advisory Committee, a cofounding principal and equity holder in Monument Analytics, and is a past member of OptumRx's National P&T Committee. No other disclosures were reported.

References

    1. 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?f...
    1. Gyawali B, Hey SP, Kesselheim AS. Assessment of the clinical benefit of cancer drugs receiving accelerated approval. JAMA Intern Med. 2019;179(7):906-913. doi:10.1001/jamainternmed.2019.0462 - DOI - PMC - PubMed
    1. 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-...
    1. Powles T, Durán I, van der Heijden MS, et al. . Atezolizumab versus chemotherapy in patients with platinum-treated locally advanced or metastatic urothelial carcinoma (IMvigor211): a multicentre, open-label, phase 3 randomised controlled trial. Lancet. 2018;391(10122):748-757. doi:10.1016/S0140-6736(17)33297-X - DOI - PubMed
    1. 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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