Project Confirm: Accelerated Drug Approvals for Chronic Myeloid Leukemia

Overview

Journal Clin Cancer Res

Specialty Oncology

Date 2022 Dec 22

PMID 36547666

Authors

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

Affiliations

Soon will be listed here.

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.

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