Friday, Apr 16, 2010

FDA Approves Tarceva as a Maintenance Therapy for Advanced Non-Small Cell Lung Cancer

First Maintenance Therapy Approved For People With Either Squamous or Non-Squamous NSCLC

South San Francisco, Calif. -- April 16, 2010 --

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," 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.


About SATURN
SATURN was an international, placebo-controlled, randomized, double-blind, Phase III study that enrolled 889 patients with advanced NSCLC at approximately 160 sites worldwide. Patients were treated with four cycles of standard first-line platinum-based chemotherapy and then randomized to Tarceva or placebo if the cancer did not progress. PFS was defined as the length of time from randomization to disease progression or death from any cause.

  • OS was significantly improved by 23 percent with Tarceva compared to placebo (hazard ratio=0.81, 19 percent reduction in the risk of death, p=0.0088).
  • People who received Tarceva had a 41 percent improvement in the likelihood of living without the disease getting worse (PFS, the primary endpoint) compared to placebo (hazard ratio=0.71, 29 percent reduction in the risk of cancer progression or death, p0.0001).
  • The most commonly reported adverse events in patients who received Tarceva as maintenance therapy were rash (49 percent) and diarrhea (20 percent). Grade 3 rash and diarrhea were experienced by six percent and two percent of patients, respectively. There were no cases of Grade 4 rash or diarrhea.


About Tarceva
Tarceva is a once-a-day pill that targets the EGFR pathway. Tarceva is designed to inhibit the tyrosine kinase activity of the EGFR signaling pathway inside the cancer cell, one of the critical growth factors in NSCLC and pancreatic cancer. The way Tarceva works to treat cancer is not fully known.


In addition to its indications in advanced NSCLC, Tarceva is also prescribed in combination with gemcitabine for patients with advanced-stage pancreatic cancer whose cancer has spread, grown, or cannot be surgically removed, and who have not received previous chemotherapy.


Tarceva Safety
There have been reports of serious Interstitial Lung Disease (ILD)-like events including deaths in patients taking Tarceva. Serious side effects (including deaths) in patients taking Tarceva include liver and/or kidney problems; gastrointestinal (GI) perforations (the development of a hole in the stomach, small intestine, or large intestine); and severe blistering skin reactions including cases similar to Stevens-Johnson syndrome. Patients taking Tarceva plus gemcitabine were more likely to experience bleeding and clotting problems such as heart attack or stroke. Eye irritation and damage to the cornea have been reported in patients taking Tarceva. Difficulty with blood clotting, and bleeding events, including gastrointestinal and non-gastrointestinal bleeding, have been reported in clinical studies. Women should avoid becoming pregnant and avoid breastfeeding while taking Tarceva. Patients should call their doctor right away if they have these signs or symptoms: new or worsening skin rash; serious or ongoing diarrhea, nausea, loss of appetite, vomiting or stomach pain; new or worsening shortness of breath or cough; fever; eye irritation. Rash and diarrhea were the most common side effects associated with Tarceva in the NSCLC clinical studies. Fatigue, rash, nausea, loss of appetite and diarrhea were the most common side effects associated with Tarceva plus gemcitabine therapy in the pancreatic cancer clinical study.


For full prescribing information, please call 1-877-TARCEVA or visit http://www.tarceva.com.


About Genentech Access Solutions
Genentech is committed to people having access to our medicines. Genentech Access Solutions is a team of 400 Genentech employees who help those who need Genentech medicines. This team works with patients and doctors to resolve reimbursement and insurance issues and provides assistance to eligible patients in the United States who do not have insurance coverage or who cannot afford their out-of-pocket co-pay costs.


Since its first medicine was approved in 1985, Genentech has donated approximately $1.5 billion in free Genentech medicines to the uninsured through the Genentech® Access to Care Foundation (GATCF) and other product donation programs. The household income limit to receive free medicine through GATCF is $100,000 per year. Since 2005, Genentech has also donated approximately $390 million to various independent, non-profit organizations that provide financial assistance to those who cannot access needed medical treatment due to co-pay costs.


About Genentech
Founded more than 30 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions. The company, a wholly owned member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com.