Colon Cancer Adjuvant Therapies Should Show 3-Year Disease-Free Survival, Cmte. Says
This article was originally published in The Pink Sheet Daily
Executive Summary
Committee members voted unanimously that disease-free survival should be used as a primary endpoint for colon cancer treatment in the adjuvant setting. The committee also voted 8-5 that progression-free survival could be used for first-line therapies.
You may also be interested in...
Eloxatin Adds Adjuvant Colorectal Cancer Claim Based On Disease-Free Survival
Sanofi-Aventis' agent is the first oncologic to be approved for an adjuvant colorectal cancer indication based on a disease-free survival endpoint. It did not demonstrate benefit in overall survival after a median follow-up of four years.
Eloxatin Adds Adjuvant Colorectal Cancer Claim Based On Disease-Free Survival
Sanofi-Aventis' agent is the first oncologic to be approved for an adjuvant colorectal cancer indication based on a disease-free survival endpoint. It did not demonstrate benefit in overall survival after a median follow-up of four years.
Prostate Cancer Trials Could Use Composite PSA/Bone Scan Endpoint, FDA's Hirschfeld Says
Presenters at an FDA public workshop on prostate cancer clinical trial endpoints agree neither PSA nor bone scan alone would be an appropriate endpoint. PSA could be used to confirm a bone scan reading, Office of Cellular, Tissue & Gene Therapies Oncology Group Leader Hirschfeld suggests.