Project Confirm: Accelerated Drug Approvals for CML—Response

Author:

Sweet Kendra L.1ORCID,Cortes Jorge E.2ORCID,Apperley Jane F.3ORCID,Mann Mel4ORCID,Mauro Michael J.5ORCID,Oehler Vivian G.6ORCID,Ruiz Cristina4ORCID,Schiffer Charles A.7ORCID,Ehrlich Lori A.8ORCID,Pamuk Gulsum E.8ORCID,Wynne Joseph8ORCID,Mehta Gautam U.8ORCID,Okusanya Olanrewaju O.8ORCID,de Claro R. Angelo8ORCID,Theoret Marc R.9ORCID,Smith B. Douglas10ORCID,Norsworthy Kelly J.8ORCID

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. 7Department of Hematology-Oncology, Karmanos Cancer Center at Wayne State University, Detroit, Michigan.

8. 8Center for Drug Evaluation and Research, FDA, Washington, District of Columbia.

9. 9Oncology Center of Excellence, FDA, Washington, District of Columbia.

10. 10The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland.

Funder

U.S. Food and Drug Administration

Publisher

American Association for Cancer Research (AACR)

Reference6 articles.

1. Project Confirm: accelerated drug approvals for chronic myeloid leukemia;Sweet;Clin Cancer Res,2023

2. Project optimus,2023

3. Coumadin prescribing information

4. Analysis of therapeutic drug monitoring in drug labels,2021

5. All optimal dosing roads lead to therapeutic drug monitoring-why take the slow lane;Beumer;JAMA Oncol,2022

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