Olaparib Review Renews Debate On Maintenance Therapy Endpoints
Oncologic Drugs Advisory Committee members divided on whether progression-free survival endpoint in AstaZeneca’s Phase III SOLO-2 trial could be used to support approval for maintenance therapy in relapsed ovarian cancer.
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AstraZeneca Takes “Anti-Avastin” Pledge On Accelerated Approval Withdrawal
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.
Genentech Likely To Wait For Survival Data For U.S. Filing Of Avastin In Ovarian Cancer
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.
Cancer Therapies Should Be Held To Higher Bar In Maintenance Setting, ODAC Says
In their review of Merck/Ariad’s Taltorvic (ridaforolimus) for sarcoma patients with stable disease, members of FDA’s Oncologic Drugs Advisory Committee suggested the nature of maintenance therapy necessitates that efficacy be more robust, and toxicities less of a concern, than in the treatment setting.