Perspectives on Drug Development for the Treatment of Chronic Myeloid Leukemia in Pregnant Patients and Patients Who Are Breastfeeding (2024)

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Volume 30, Issue 17

1 September 2024

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CCR Perspectives in Regulatory Science and Policy| September 03 2024

Jorge E. Cortes

;

Jorge E. Cortes *

1

Georgia Cancer Center at Augusta University, Augusta, Georgia.

*Corresponding Author: Jorge E. Cortes, Georgia Cancer Center, 1410 Laney Walker Road, CN2222, Augusta, GA 30912. E-mail: jorge.cortes@augusta.edu

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Elisabetta Abruzzese

;

Elisabetta Abruzzese

2

Hematology, S. Eugenio Hospital, Tor Vergata University, Rome, Italy.

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Elyce H. Cardonick

;

Elyce H. Cardonick

3

Cooper Medical School of Rowan University, Camden, New Jersey.

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Sonia Hernández-Díaz

;

Sonia Hernández-Díaz

4

Harvard T.H. Chan School of Public Health, Boston, Massachusetts.

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Jamie Gutierrez

;

Jamie Gutierrez

5

Patient advocate, Castle Pines, Colorado.

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Erica Torres-Chavez

;

Erica Torres-Chavez

7

Patient advocate, Riverside, California.

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Miriam Dinatale

;

Miriam Dinatale

8

FDA, Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine, Silver Spring, Maryland.

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Catherine C. Lerro

;

Catherine C. Lerro

9

FDA, Oncology Center of Excellence, Silver Spring, Maryland.

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Brenda J. Gehrke

;

Brenda J. Gehrke

10

FDA, Center for Drug Evaluation and Research, Office of Oncologic Diseases, Silver Spring, Maryland.

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Stacy S. Shord

;

Stacy S. Shord

11

FDA, Center for Drug Evaluation and Research, Office of Clinical Pharmacology, Silver Spring, Maryland.

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R. Angelo De Claro

;

R. Angelo De Claro

10

FDA, Center for Drug Evaluation and Research, Office of Oncologic Diseases, Silver Spring, Maryland.

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Marc R. Theoret

;

Marc R. Theoret

9

FDA, Oncology Center of Excellence, Silver Spring, Maryland.

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Peter J. DeMaria

;

Peter J. DeMaria

8

FDA, Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine, Silver Spring, Maryland.

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Kelly J. Norsworthy

Kelly J. Norsworthy

10

FDA, Center for Drug Evaluation and Research, Office of Oncologic Diseases, Silver Spring, Maryland.

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Author & Article Information

*Corresponding Author: Jorge E. Cortes, Georgia Cancer Center, 1410 Laney Walker Road, CN2222, Augusta, GA 30912. E-mail: jorge.cortes@augusta.edu

Clin Cancer Res 2024;30:3658–66

Received: March 19 2024

Revision Received: May 17 2024

Accepted: July 03 2024

Online ISSN: 1557-3265

Print ISSN: 1078-0432

Funding

Funding Group:

  • Award Group:

    • Funder(s):

      U.S. Food and Drug Administration (FDA)

    • Principal Award Recipient(s):

      C.C.

      Lerro

      ,

      B.J.

      Gehrke

      ,

      S.S.

      Shord

      ,

      R.

      Angelo de Claro

      ,

      M.R.

      Theoret

      ,

      M.

      Dinatale

      ,

      P.J.

      DeMaria

      ,

      K.J.

      Norsworthy

©2024 American Association for Cancer Research

2024

American Association for Cancer Research

Clin Cancer Res (2024) 30 (17): 3658–3666.

Article history

Received:

March 19 2024

Revision Received:

May 17 2024

Accepted:

July 03 2024

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    • Version of Record September 3 2024
    • Proof July 23 2024
    • Accepted Manuscript July 5 2024

Citation

Jorge E. Cortes, Elisabetta Abruzzese, Elyce H. Cardonick, Sonia Hernández-Díaz, Jamie Gutierrez, Mary S. Sardegna, Erica Torres-Chavez, Miriam Dinatale, Catherine C. Lerro, Brenda J. Gehrke, Stacy S. Shord, R. Angelo De Claro, Marc R. Theoret, Peter J. DeMaria, Kelly J. Norsworthy; Perspectives on Drug Development for the Treatment of Chronic Myeloid Leukemia in Pregnant Patients and Patients Who Are Breastfeeding. Clin Cancer Res 1 September 2024; 30 (17): 3658–3666. https://doi.org/10.1158/1078-0432.CCR-24-0826

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Abstract

Tyrosine kinase inhibitors (TKI) have improved the outcome and life expectancy of patients with chronic myeloid leukemia (CML). Patients are diagnosed with CML at younger ages, and patients treated for CML may become pregnant or choose to breastfeed. The information available to date on the safety of TKIs during pregnancy and lactation and the optimal management of these patients is largely anecdotal, based on personal or small-group experience, and heterogeneous. A panel of interested parties was convened by U.S. Food and Drug Administration to analyze the current data and discuss possible solutions. Possible solutions include prospective data collection, in clinical trials and in routine clinical practice, a more uniform and specific data collection, and greater coordination among involved entities. As patients with cancer are living longer, frequently receiving therapies for extended periods of time (or for life), data on appropriate management of patients through different reproductive phases of life are needed. It is thus time to change our approach for how to study treatment of cancer (including CML) during pregnancy or breastfeeding to develop evidence-based guidelines for safe and effective patient care.

©2024 American Association for Cancer Research

2024

American Association for Cancer Research

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