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.
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Roche’s former chief medical officer has new career as board member to three companies, including COVID-19 vaccine pioneer Moderna, and is co-founder of a startup seeking to develop more affordable drugs. She helped pave the way for FDA’s breakthrough therapy designation and diversification of Genentech’s clinical trials.
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.