Avastin Debate Could Provide Clarity On Use Of 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 FDA expects the magnitude of PFS benefit to be defined.
You may also be interested in...
21st Century Cures legislation also criticized in JAMA Internal Medicine editorial.
Sponsor says it would offer to remove olaparib from the market if results from ongoing SOLO-2 trial in ovarian cancer maintenance setting are “not consistent” with Phase II efficacy data upon which accelerated approval is requested.
Submitting an NDA based on progression-free survival when other drugs for the indication have been approved on the basis of overall survival benefits is a risky proposition, but GlaxoSmithKline was confident the magnitude of Mekinist and Tafinlar’s PFS effect in metastatic melanoma would make the findings clinically relevant.