Avastin Ovarian Cancer Approval Brings Some Clarity On PFS Endpoint
New claim for platinum-resistant recurrent disease based on a median 3.4-month improvement in progression-free survival – with favorable trends in overall survival, overall response rate and duration of response – confirms agency’s willingness to entertain a progression endpoint in this tumor type.
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Genentech says it worked closely with the agency to bring the drug to women with earlier-stage disease.
The latest drug development news and highlights from our FDA Performance Tracker.
AstraZeneca’s Lynparza was rejected as a maintenance therapy after second-line treatment by an FDA advisory committee, but landed accelerated approval for heavily pretreated relapsed patients, based on data not considered in the initial advisory committee review.