GEN Exclusives

More »

GEN Poll

Dec 13, 2011

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 But last year FDA’s CDER recommended that MBC be withdrawn since subsequent studies showed only a small improvement in OS.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?

Should the primary endpoint for approval of cancer drugs change to progression-free survival from overall survival?


Related content


GEN Jobs powered by connects you directly to employers in pharma, biotech, and the life sciences. View 40 to 50 fresh job postings daily or search for employment opportunities including those in R&D, clinical research, QA/QC, biomanufacturing, and regulatory affairs.
More »