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. 2022 Apr;19(4):217-218.
doi: 10.1038/s41571-022-00605-5.

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

Steven Lemery  1 , Richard Pazdur  2   3
Affiliations

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

Steven Lemery et al. Nat Rev Clin Oncol. 2022 Apr.

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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Conflict of interest statement

The authors declare no competing interests.

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