In which types of NSCLC patients is Tarceva use appropriate?
Tarceva monotherapy is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of at least one prior chemotherapy regimen. Results from two, multicenter, placebo-controlled, randomized, Phase III trials conducted in first-line patients with locally advanced or metastatic NSCLC showed no clinical benefit with the concurrent administration of Tarceva with platinum-based chemotherapy [carboplatin and paclitaxel or gemcitabine and cisplatin] and its use is not recommended in that setting. In the pivotal clinical trial for NSCLC, there was a significant survival benefit for a large, unselected group of patients receiving Tarceva monotherapy. Tarceva significantly improved overall survival by 37% vs placebo in these pretreated NSCLC patients (HR=0.73; 95% CI=0.61-0.86; P<0.001). While Tarceva provides a proven survival benefit across a diverse patient population in the 2nd and 3rd line, retrospective analysis of BR.21 demonstrates
