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. 2021 May 3;4(5):e2112558.
doi: 10.1001/jamanetworkopen.2021.12558.

Assessment of New Molecular Entities Approved for Cancer Treatment in 2020

Affiliations

Assessment of New Molecular Entities Approved for Cancer Treatment in 2020

Claire E P Smith et al. JAMA Netw Open. .

Abstract

This cross-sectional study of all hematology/oncology drugs approved by the US Food and Drug Administration in 2020 assesses the functioning of the drug approval process following disruptions related to the COVID-19 pandemic.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Prasad reported receiving grant funding from Arnold Ventures during the conduct of the study; he reported receiving publishing royalties from Johns Hopkins University Press, Medscape, and MedPage; he reported receiving consulting fees from UnitedHealthcare; he reported receiving speaking fees from Evicore, New Century Health, and Patreon Plenary Session podcast outside the submitted work. No other disclosures were reported.

Figures

Figure.
Figure.. Response Rate and Complete Response Rate of Novel Cancer Drugs Approved in 2020
The overall median response rate was 49.7%. Note that for tazemetostat, only the response rate (69%) in follicular lymphoma is shown; the response rate for epithelioid sarcoma is 15%. aDenotes a drug approved based upon a randomized placebo-controlled trial.

References

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    1. US Food and Drug Administration . FDA Approves First Treatment for COVID-19. Food and Drug Administration news release. Published October 22, 2020. Accessed December 4, 2020. https://www.fda.gov/news-events/press-announcements/fda-approves-first-t...
    1. Hahn SM (@SteveFDA). As we make progress in our understanding of #COVID19, we continue full speed ahead on our non-COVID cancer-related work, including important drug approvals. For instance, as of Oct. 30, the @US_FDA has approved 42 novel drugs including 15 new drugs to treat patients with various forms of cancer. Several of these approvals have been “firsts” for oncology. November 17, 2020. Accessed April 15, 2021. https://twitter.com/stevefda/status/1328800222449979392
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