Highlights of FDA Oncology Approvals in 2023: Bispecific T-cell Engagers, Pediatric Indications, and Inclusive Drug Development

Joshua M Donaldson; Marjilla Seddiq; Michael J Fusco; Shyamli Singla; Gulsum E Pamuk; Rosa J Lee-Alonso; Bronwyn D Mixter; Kirsten B Goldberg; Laleh Amiri-Kordestani; R Angelo de Claro; Nicole Drezner; Nicole J Gormley; Bindu Kanapuru; Steven J Lemery; Lola A Fashoyin-Aje; Nicholas C Richardson; Harpreet Singh; Daniel L Suzman; Marc R Theoret; Paul G Kluetz; Richard Pazdur

doi:10.1158/2159-8290.CD-23-1226

Highlights of FDA Oncology Approvals in 2023: Bispecific T-cell Engagers, Pediatric Indications, and Inclusive Drug Development

Cancer Discov. 2023 Dec 12;13(12):2515-2524. doi: 10.1158/2159-8290.CD-23-1226.

Authors

Joshua M Donaldson¹, Marjilla Seddiq¹, Michael J Fusco¹, Shyamli Singla¹, Gulsum E Pamuk¹, Rosa J Lee-Alonso², Bronwyn D Mixter², Kirsten B Goldberg², Laleh Amiri-Kordestani^{1

2}, R Angelo de Claro^{1

2}, Nicole Drezner¹, Nicole J Gormley^{1

2}, Bindu Kanapuru¹, Steven J Lemery^{1

2}, Lola A Fashoyin-Aje^{1

2}, Nicholas C Richardson¹, Harpreet Singh^{1

2}, Daniel L Suzman¹, Marc R Theoret^{1

2}, Paul G Kluetz^{1

2}, Richard Pazdur^{1

2}

Affiliations

¹ Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
² Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland.

PMID: 38084090
DOI: 10.1158/2159-8290.CD-23-1226

Abstract

Cancer drug development remained robust in 2023. Highlights of U.S. drug approvals this year include new immunotherapies and targeted drug development in adult and pediatric patients as well as patients with rare diseases.

MeSH terms

Antineoplastic Agents* / therapeutic use
Child
Drug Approval
Humans
Immunotherapy
Neoplasms* / drug therapy
T-Lymphocytes
United States
United States Food and Drug Administration

Substances

Antineoplastic Agents