Sentences with phrase «accelerated approval based»
This indication is approved under accelerated approval based on MRD response rate and hematological relapse - free survival.
https://www.cnbc.com/ Not exact matches
These patients» individual stories, as told via the media or testimony on Capitol Hill, may be more compelling than arguments based on data and may thus contribute to the rising pressure to accelerate FDA approvals, according to bioethicist Bernard Lo, who is president of the Greenwall Foundation.
The FDA approved the combination of Mekinist and Tafinlar through its accelerated approval program, which allows the agency to approve drugs to treat a serious disease based on clinical data showing the therapy has a proven effect and clinical benefit to patients.
The FDA's accelerated approval regulatory option, for example, is specifically designed to allow FDA validation based on studies measuring «surrogate endpoints.»
The FDA granted the approval in August on an accelerated basis, after only 24 weeks of data collection during a clinical trial.
In 2009, bevacizumab (Avastin ®) was granted accelerated approval for the treatment of GBM patients whose cancers had recurred, based on results from two phase II studies.
Based on the results of this small - scale study, in May 2017, the U.S. Food and Drug Administration granted accelerated approval to this combination regimen.