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When Oncology NDAs Fail, Clinical Benefit Is Often In Question

 
• By Bridget Silverman

Pre-submission meetings can address questions of clinically meaningful endpoints and appropriate subgroups, avoiding negative regulatory outcomes, FDA analysis suggests.

Common flaws in oncology NDAs that fail to receive approval could have been addressed by the pre-submission meetings encouraged under FDA’s program to increase review efficiency, an agency analysis of failed new molecular entity oncology NMEs concluded.

Many of the failed applications tried to assert a drug benefit without well-controlled trials showing a statistically significant effect on a clinically meaningful primary endpoint, preferably survival – the gold...

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