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      Approvals in 2021: dangling Accelerated Approvals, drug dosing, new approvals and beyond

      brief-report
      Author(s): 1 , , 1 , 2
      Publication date (Electronic):
      Journal: Nature Reviews. Clinical Oncology
      Publisher: Nature Publishing Group UK
      Keywords: Oncology, Cancer therapy

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          Abstract

          In 2021, policy areas of focus for FDA Oncology included the Accelerated Approval programme, expanding eligibility criteria, dose optimization and patient-reported outcomes. The FDA continued to be active with approvals of both new drugs and supplementary applications, including three new chimeric antigen receptor T cell products, two antibody–drug conjugates and several new targeted agents.

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          The Drug-Dosing Conundrum in Oncology — When Less Is More

          Mirat Shah, Atiqur Rahman, Marc R Theoret … (2021)
          Article 0 comments Cited 63 times – based on 0 reviews     Review now
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            “Dangling” Accelerated Approvals in Oncology

            Julia Beaver, Richard Pazdur (2021)
            Article 0 comments Cited 36 times – based on 0 reviews     Review now
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              The Wild West of Checkpoint Inhibitor Development

              Julia A. Beaver, Richard Pazdur (2021)
              Article 0 comments Cited 34 times – based on 0 reviews     Review now
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                Author and article information

                Contributors
                Steven Lemery: Steven.Lemery@fda.hhs.gov
                Journal
                Journal ID (nlm-ta): Nat Rev Clin Oncol
                Journal ID (iso-abbrev): Nat Rev Clin Oncol
                Title: Nature Reviews. Clinical Oncology
                Publisher: Nature Publishing Group UK (London )
                ISSN (Print): 1759-4774
                ISSN (Electronic): 1759-4782
                Publication date (Electronic): 8 February 2022
                Pages: 1-2
                Affiliations
                [1 ]GRID grid.417587.8, ISNI 0000 0001 2243 3366, Office of Oncologic Diseases, Center for Drug Evaluation and Research, , US Food and Drug Administration, ; Silver Spring, MD USA
                [2 ]GRID grid.417587.8, ISNI 0000 0001 2243 3366, Oncology Center of Excellence, , US Food and Drug Administration, ; Silver Spring, MD USA
                Article
                Publisher ID: 605
                DOI: 10.1038/s41571-022-00605-5
                PMC ID: 8824437
                PubMed ID: 35136230
                SO-VID: e436b376-1d2e-453c-8265-3411c1f1dcbc
                Copyright © © This is a U.S. government work and not under copyright protection in the U.S.; foreign copyright protection may apply 2022
                License:

                This article is made available via the PMC Open Access Subset for unrestricted research re-use and secondary analysis in any form or by any means with acknowledgement of the original source. These permissions are granted for the duration of the World Health Organization (WHO) declaration of COVID-19 as a global pandemic.

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                Subject: Comment

                Keywords: oncology,cancer therapy
                Data availability:
                Keywords: oncology, cancer therapy

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