Highlights of FDA Oncology Approvals in 2022: Tissue-Agnostic Indications, Dosage Optimization, and Diversity in Drug Development-Reference-Cited by-同舟云学术

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

Published:2022-12-02 Issue:12 Volume:12 Page:2739-2746
ISSN:2159-8274
Container-title:Cancer Discovery
language:en
Short-container-title:

Author:

Duke Elizabeth S.¹^ORCID,J. Fusco Michael¹^ORCID,DeMoss Patrick¹^ORCID,Dilawari Asma¹^ORCID,Pamuk Gulsum E.¹^ORCID,Boehmer Jessica²^ORCID,Mixter Bronwyn²^ORCID,Goldberg Kirsten B.²^ORCID,Kluetz Paul¹²^ORCID,Pazdur Richard¹²^ORCID

Affiliation:

1. 1Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.

2. 2Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland.

Abstract

Summary: In 2022, cancer drug development continued to progress rapidly despite the lingering COVID-19 pandemic. 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.

Publisher

American Association for Cancer Research (AACR)

Subject

Oncology

Link

https://aacrjournals.org/cancerdiscovery/article-pdf/12/12/2739/3227774/2739.pdf

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