Project Confirm: Accelerated Drug Approvals for Chronic Myeloid Leukemia.

Autor:	Sweet KL; Moffitt Cancer Center, Tampa, Florida., Cortes JE; Georgia Cancer Center, Augusta University, Augusta, Georgia., Apperley JF; Centre for Haematology, Imperial College, London, United Kingdom., Mann M; Patient Advocate, Jonesboro, Georgia., Mauro MJ; Myeloproliferative Neoplasms Program, Memorial Sloan Kettering Cancer Center, New York City, New York., Oehler VG; Fred Hutchinson Cancer Research Center, Seattle Cancer Care Alliance, Seattle, Washington., Ruiz C; Patient Advocate, Los Angeles, California., Schiffer CA; Department of Hematology-Oncology, Karmanos Cancer Center at Wayne State University, Detroit, Michigan., Ehrlich LA; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Washington, DC., Pamuk GE; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Washington, DC., Wynne J; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Washington, DC., Mehta GU; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Washington, DC., de Claro RA; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Washington, DC., Theoret MR; Oncology Center of Excellence, U.S. Food and Drug Administration, Washington, DC., Smith BD; The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland., Norsworthy KJ; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Washington, DC.
Jazyk:	angličtina
Zdroj:	Clinical cancer research : an official journal of the American Association for Cancer Research [Clin Cancer Res] 2023 Jun 13; Vol. 29 (12), pp. 2179-2183.
DOI:	10.1158/1078-0432.CCR-22-2628
Abstrakt:	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. (©2022 American Association for Cancer Research.)
Databáze:	MEDLINE
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