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Genentech Likely To Wait For Survival Data For U.S. Filing Of Avastin In Ovarian Cancer

 
• By Emily Hayes

Avastin proves progression-free survival benefit for tough-to-treat patients in AURELIA, the drug’s fourth positive Phase III ovarian cancer study. Genentech says it plans to “engage” with FDA regarding a filing, but acknowledges that the agency may want more data, possibly showing an overall survival benefit.

CHICAGO––Roche/Genentech Inc.may hold off on an ovarian cancer filing for its VEGF inhibitor Avastin (bevacizumab) even though it now has data from four positive Phase III trials, including the AURELIA study in hard-to-treat platinum-resistant patients presented at the American Society of Clinical Oncology meeting June 2. In part because of its experience with the now-withdrawn breast cancer indication, the company is signaling it may wait for overall survival data.

The first study of Avastin in ovarian cancer, GOG-0218, debuted at ASCO in 2010, followed quickly by ICON-7. At that time, company said that progression-free survival was an acceptable endpoint in front-line ovarian cancer Also see "Roche's Long View: ASCO Marks Progress In Shifting To Lengthier Treatment Duration For Avastin, Rituxan" - Pink Sheet, 14 June, 2010.. The OCEANS study in platinum-sensitive disease reported in 2011 Also see "Ovarian Cancer: Roche's Avastin And Others Show Potential, But Also Raise The "Value" Question" - Pink Sheet, 13 June, 2011.

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