Executive Summary

Erbitux significantly prolongs survival in first-line NSCLC: The addition of Bristol-Myers Squibb/ImClone/Merck KGaA's Erbitux (cetuximab) to platinum-based chemotherapy significantly increased overall survival in first-line treatment of non-small cell lung cancer, the first targeted therapy to show a significant survival benefit in NSCLC patients across all histological subtypes. In the Phase III FLEX trial, presented at the June 1 ASCO plenary session, over 1,000 patients with stage IIIB or IV NSCLC were randomized to receive Erbitux plus chemotherapy or chemo alone. Median overall survival was 11.3 months for the Erbitux arm versus 10.1 months for chemotherapy alone. The sponsors are discussing with FDA their plans to use the data as the basis of a supplemental BLA filing, which they hope to submit at the end of this year. Erbitux is approved for treatment of metastatic colorectal cancer after failure of both irinotecan- and oxaliplatin-based regimens, and as a single agent for metastatic CRC in patients intolerant to irinotecan