Project Confirm: Accelerated Drug Approvals for Chronic Myeloid Leukemia-Reference-Cited by-同舟云学术

Project Confirm: Accelerated Drug Approvals for Chronic Myeloid Leukemia

Published:2023-01-10 Issue: Volume: Page:OF1-OF5
ISSN:1078-0432
Container-title:Clinical Cancer Research
language:en
Short-container-title:

Author:

Sweet Kendra L.¹^ORCID,Cortes Jorge E.²^ORCID,Apperley Jane F.³^ORCID,Mann Mel⁴^ORCID,Mauro Michael J.⁵^ORCID,Oehler Vivian G.⁶^ORCID,Ruiz Cristina⁷^ORCID,Schiffer Charles A.⁸^ORCID,Ehrlich Lori A.⁹^ORCID,Pamuk Gulsum E.⁹^ORCID,Wynne Joseph⁹^ORCID,Mehta Gautam U.⁹^ORCID,de Claro R. Angelo⁹^ORCID,Theoret Marc R.¹⁰^ORCID,Smith B. Douglas¹¹^ORCID,Norsworthy Kelly J.⁹^ORCID

Affiliation:

1. 1Moffitt Cancer Center, Tampa, Florida.

2. 2Georgia Cancer Center, Augusta University, Augusta, Georgia.

3. 3Centre for Haematology, Imperial College, London, United Kingdom.

4. 4Patient Advocate, Jonesboro, Georgia.

5. 5Myeloproliferative Neoplasms Program, Memorial Sloan Kettering Cancer Center, New York City, New York.

6. 6Fred Hutchinson Cancer Research Center, Seattle Cancer Care Alliance, Seattle, Washington.

7. 7Patient Advocate, Los Angeles, California.

8. 8Department of Hematology-Oncology, Karmanos Cancer Center at Wayne State University, Detroit, Michigan.

9. 9Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Washington, DC.

10. 10Oncology Center of Excellence, U.S. Food and Drug Administration, Washington, DC.

11. 11The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland.

Abstract

Abstract The FDA has an accelerated approval program for drugs that have been identified as promising treatments for serious conditions when the available data suggest that the benefits outweigh the foreseeable risks. All of the currently available treatment options for chronic myeloid leukemia (CML) initially went through the accelerated approval program. Here, a group of academic CML experts, patient panelists, and members from the FDA convened to discuss the utility of the accelerated approval program as it pertains to CML, and the utility of this program in future drug development in this disease. The results of that discussion are summarized here.

Publisher

American Association for Cancer Research (AACR)

Subject

Cancer Research,Oncology

Link

https://aacrjournals.org/clincancerres/article-pdf/doi/10.1158/1078-0432.CCR-22-2628/3233039/ccr-22-2628.pdf

Cited by 2 articles. 订阅此论文施引文献订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献

1. Project Confirm: Accelerated Drug Approvals for CML—Response;Clinical Cancer Research;2024-01-05

2. Project Confirm: Accelerated Drug Approvals for CML—Letter;Clinical Cancer Research;2024-01-05