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

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

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

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In Focus| December 12 2023

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

Joshua M. Donaldson

0000-0003-3879-833X

;

Joshua M. Donaldson *

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

*Corresponding Author: Joshua M. Donaldson, Office of Oncologic Diseases, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993. E-mail: Joshua.Donaldson@fda.hhs.gov

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Marjilla Seddiq

0000-0003-1436-2136

;

Marjilla Seddiq

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

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Michael J. Fusco

0000-0002-5883-7466

;

Michael J. Fusco

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

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Shyamli Singla

0009-0001-2828-2412

;

Shyamli Singla

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

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Gulsum E. Pamuk

0000-0002-2299-3758

;

Gulsum E. Pamuk

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

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Rosa J. Lee-Alonzo

0009-0007-9823-599X

;

Rosa J. Lee-Alonzo

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

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Bronwyn D. Mixter

0000-0001-5277-4399

;

Bronwyn D. Mixter

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

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Kirsten B. Goldberg

0000-0001-8659-1240

;

Kirsten B. Goldberg

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

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Laleh Amiri-Kordestani

0000-0002-0056-5437

;

Laleh Amiri-Kordestani

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

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

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R. Angelo de Claro

0000-0001-8362-1977

;

R. Angelo de Claro

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

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

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Nicole Drezner

0000-0001-6299-9823

;

Nicole Drezner

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

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Nicole J. Gormley

0000-0001-6379-5101

;

Nicole J. Gormley

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

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

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Bindu Kanapuru

0000-0003-1341-4686

;

Bindu Kanapuru

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

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Steven J. Lemery

0000-0001-7415-1870

;

Steven J. Lemery

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

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

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Lola A. Fashoyin-Aje

0000-0001-7328-7813

;

Lola A. Fashoyin-Aje

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

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

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Nicholas C. Richardson

0000-0001-9378-9909

;

Nicholas C. Richardson

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

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Harpreet Singh

0000-0003-1526-0916

;

Harpreet Singh

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

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

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Daniel L. Suzman

0000-0002-1702-6114

;

Daniel L. Suzman

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

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Marc R. Theoret

0000-0003-4973-5297

;

Marc R. Theoret

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

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

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Paul G. Kluetz

0000-0002-9796-4791

;

Paul G. Kluetz

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

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

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Richard Pazdur

0000-0002-4771-9923

Richard Pazdur

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

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

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Author & Article Information

*Corresponding Author: Joshua M. Donaldson, Office of Oncologic Diseases, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993. E-mail: Joshua.Donaldson@fda.hhs.gov

Cancer Discov 2023;13:2515–24

Online ISSN: 2159-8290

Print ISSN: 2159-8274

2023

American Association for Cancer Research

Cancer Discov (2023) 13 (12): 2515–2524.

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

Summary:

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.

2023

American Association for Cancer Research

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

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