Project Confirm: Accelerated Drug Approvals for Chronic Myeloid Leukemia

Kendra L. Sweet; Jorge E. Cortes; Jane F. Apperley; Mel Mann; Michael J. Mauro; Vivian G. Oehler; Cristina Ruiz; Charles A. Schiffer; Lori A. Ehrlich; Gulsum E. Pamuk; Joseph Wynne; Gautam U. Mehta; R. Angelo de Claro; Marc R. Theoret; B. Douglas Smith; Kelly J. Norsworthy

doi:10.1158/1078-0432.CCR-22-2628

Project Confirm: Accelerated Drug Approvals for Chronic Myeloid Leukemia

Kendra L. Sweet, Jorge E. Cortes, Jane F. Apperley, Mel Mann, Michael J. Mauro, Vivian G. Oehler, Cristina Ruiz, Charles A. Schiffer, Lori A. Ehrlich, Gulsum E. Pamuk, Joseph Wynne, Gautam U. Mehta, R. Angelo de Claro, Marc R. Theoret, B. Douglas Smith, Kelly J. Norsworthy

Medicine

Research output: Contribution to journal › Article › peer-review

2 Scopus citations

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.

Original language	English (US)
Pages (from-to)	2179-2183
Number of pages	5
Journal	Clinical cancer research : an official journal of the American Association for Cancer Research
Volume	29
Issue number	12
DOIs	https://doi.org/10.1158/1078-0432.CCR-22-2628
State	Published - Jun 13 2023

ASJC Scopus subject areas

General Medicine

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10.1158/1078-0432.CCR-22-2628

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Sweet, K. L., Cortes, J. E., Apperley, J. F., Mann, M., Mauro, M. J., Oehler, V. G., Ruiz, C., Schiffer, C. A., Ehrlich, L. A., Pamuk, G. E., Wynne, J., Mehta, G. U., de Claro, R. A., Theoret, M. R., Smith, B. D., & Norsworthy, K. J. (2023). Project Confirm: Accelerated Drug Approvals for Chronic Myeloid Leukemia. Clinical cancer research : an official journal of the American Association for Cancer Research, 29(12), 2179-2183. https://doi.org/10.1158/1078-0432.CCR-22-2628

Sweet, KL, Cortes, JE, Apperley, JF, Mann, M, Mauro, MJ, Oehler, VG, Ruiz, C, Schiffer, CA, Ehrlich, LA, Pamuk, GE, Wynne, J, Mehta, GU, de Claro, RA, Theoret, MR, Smith, BD & Norsworthy, KJ 2023, 'Project Confirm: Accelerated Drug Approvals for Chronic Myeloid Leukemia', Clinical cancer research : an official journal of the American Association for Cancer Research, vol. 29, no. 12, pp. 2179-2183. https://doi.org/10.1158/1078-0432.CCR-22-2628

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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.",

author = "Sweet, {Kendra L.} and Cortes, {Jorge E.} and Apperley, {Jane F.} and Mel Mann and Mauro, {Michael J.} and Oehler, {Vivian G.} and Cristina Ruiz and Schiffer, {Charles A.} and Ehrlich, {Lori A.} and Pamuk, {Gulsum E.} and Joseph Wynne and Mehta, {Gautam U.} and {de Claro}, {R. Angelo} and Theoret, {Marc R.} and Smith, {B. Douglas} and Norsworthy, {Kelly J.}",

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doi = "10.1158/1078-0432.CCR-22-2628",

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AU - Mauro, Michael J.

AU - Oehler, Vivian G.

AU - Ruiz, Cristina

AU - Schiffer, Charles A.

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AU - Mehta, Gautam U.

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AU - Norsworthy, Kelly J.

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Project Confirm: Accelerated Drug Approvals for Chronic Myeloid Leukemia

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