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The FDA's accelerated approval program allows for faster access to promising drugs for serious conditions when benefits are believed to outweigh risks.
All current treatments for chronic myeloid leukemia (CML) were approved through this program.
A meeting with CML experts, patients, and FDA representatives explored the effectiveness of this program for CML and its potential impact on future drug development.
Article 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.
