Black box vs. Avastin

Although PTK/ZK (PTK787) from Novartis AG and Schering AG recently missed the primary endpoint of progression-free survival as assessed by central radiology review in the Phase III CONFIRM 1 colorectal cancer trial, it may be too soon to conclude that the product is a failure. Progression-free survival achieved statistical significance when assessed by investigators, a secondary endpoint, although that may be a more biased assessment than central review.

In addition, an independent data monitoring board recommended that the international trial in 1,168 treatment-naive patients continue in order to allow analysis of another primary endpoint: overall survival(see B13).In CONFIRM 1, PTK/ZK was given in combination with the oxaliplatin/5-FU/leucovorin (FOLFOX-4) chemotherapy regimen...