Roche's Tarceva cleared for NSCLS maintenance in EU; taspoglutide positive in Ph III diabetes trial; milestone for Osiris from JCR

Swiss drug major Roche says that the European Commission has approved its cancer drug Tarceva (erlotinib), marketed under license from USA-based OSI Pharmaceuticals, as monotherapy for maintenance treatment in patients with advanced non-small cell lung cancer (NSCLC) whose disease remains largely unchanged (known as stable disease) after platinum-based initial chemotherapy.

The approval is based on data from the pivotal SATURN study which showed that compared to placebo Tarceva gave patients with stable disease a 39% improvement in overall survival (OS) and a 2.3 month improvement in median survival (11.9 months versus 9.6 months).

Earlier this month, the US Food and Drug Administration approved Tarceva as a maintenance treatment for patients with locally advanced or metastatic NSCLC whose disease has not progressed after four cycles of platinum-based first-line chemotherapy (The Pharma Letter April 19). The drug, which is now approved in 109 countries for advanced NSCLC and in 80 for pancreatic cancer, generated sales of $1.2 billion last year.