Genentech's Tarceva receives FDA approval as maintenance therapy for advanced NSCLC

Genentech, Inc., a wholly owned member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) approved the daily pill Tarceva^® (erlotinib) as a maintenance treatment for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose disease has not progressed after four cycles of platinum-based first-line chemotherapy.

“We hope this approval will help more people fight the leading cause of cancer death in the United States”

"We hope this approval will help more people fight the leading cause of cancer death in the United States," said Hal Barron, executive vice president, Global Development and chief medical officer. "Tarceva is the first oral maintenance option for people with advanced NSCLC who want to continue treating their cancer before it grows or spreads again."

The new approval for Tarceva was based on data from the pivotal Phase III SATURN study. SATURN showed that Tarceva given as a maintenance therapy immediately after first-line chemotherapy significantly extended overall survival (OS) and significantly improved the time people with advanced NSCLC lived without the disease getting worse (progression-free survival, PFS), including people with either squamous or non-squamous NSCLC, compared with placebo. The goal of maintenance therapy, a new approach in lung cancer, is to provide an active treatment for people whose disease either responded to, or was stable, following initial chemotherapy before their cancer worsens. Many people are unable to receive further treatment after their cancer grows or spreads because of rapid cancer growth and worsening symptoms.

Tarceva is already FDA-approved for people with advanced NSCLC whose cancer has grown or spread after receiving at least one course of chemotherapy. Tarceva is not meant to be used at the same time as certain types of chemotherapy for NSCLC.

According to the American Cancer Society, lung cancer is the leading cause of cancer death in the United States and approximately 159,000 Americans died from the disease in 2009. NSCLC is the most common type of lung cancer. Most people are diagnosed with advanced stage disease and only one to five percent of people with advanced stage (IIIB/IV) NSCLC survive five years.

SOURCE Genentech, Inc.,