Highlights of FDA Oncology Approvals in 2022: Tissue-Agnostic Indications, Dosage Optimization, and Diversity in Drug Development

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Abstract

In 2022, cancer drug development continued to progress rapidly despite the lingering COVID-19 pan-demic. Highlights of U.S. drug approvals for oncology indications this year include ongoing development in rare diseases and molecular subgroups, improved dosage optimization, and updated data for drugs granted accelerated approval, with confirmatory studies demonstrating verification of clinical benefit in some instances, as well as indication withdrawal when clinical benefit was not verified.

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Duke, E. S., Fusco, M. J., Demoss, P., Dilawari, A., Pamuk, G. E., Boehmer, J., … Pazdur, R. (2022). Highlights of FDA Oncology Approvals in 2022: Tissue-Agnostic Indications, Dosage Optimization, and Diversity in Drug Development. Cancer Discovery, 12(12), 2736–2746. https://doi.org/10.1158/2159-8290.CD-22-1185

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