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After Avastin, Seeking Clarity On Progression-Free Survival Endpoints

Rather than damaging the use of progression-free survival as an endpoint in oncology clinical trials, as some have feared, the battle over Avastin’s (bevacizumab) metastatic breast cancer claim could give sponsors some clarity as to how the US FDA expects the magnitude of progression-free survival benefit to be defined.

Rather than damaging the use of progression-free survival as an endpoint in oncology clinical trials, as some have feared, the battle over Avastin's (bevacizumab) metastatic breast cancer claim could give sponsors some clarity as to how the US Food and Drug Administration expects the magnitude of progression-free survival (PFS) benefit to be defined. Discussion at FDA's June 28-29 hearing on Avastin's metastatic breast cancer (MBC) claim suggests that while PFS remains a usable endpoint in some cancer settings, drug companies should not pin their hopes for a therapy's regulatory success on a strong PFS to hazard ratio. Rather, they need to look at the entire picture, including a treatment's impact on median PFS values.

Despite Genentech Inc.'s (part of Roche) protestations that the hazard ratio, a statistical measure for calculating risk reduction, is a more appropriate measure of a therapy's efficacy than...

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