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OS vs. PFS
FDA’s success in removing Avastin’s metastatic breast cancer (MBC) indication has sparked a longstanding debate in drug development circles: Should the primary endpoint for regulatory sanction remain overall survival (OS) or should it change to progression-free survival (PFS)? In Avastin’s case, initial accelerated approval, in combination with paclitaxel, for MBC was based on PFS data. But last year FDA’s CDER recommended that MBC be withdrawn since subsequent studies showed only a small improvement in OS. FDA also noted that Avastin’s PFS improvement was not worth the risk of associated side effects. Avastin maker Genentech and parent Roche countered that PFS should be the primary endpoint, because it could be objectively measured and because the EU recognized it as an oncology endpoint. Where do you stand?