FDA approves Tarceva (erlotinib)

OSI Pharmaceuticals and Genentech have announced that the U.S. Food and Drug Administration (FDA) has approved, after priority review, Tarceva (erlotinib) for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure of at least one prior chemotherapy regimen.

Tarceva is an oral tablet indicated for daily administration. Tarceva is the only drug in the epidermal growth factor receptor (EGFR) class to demonstrate in a Phase III clinical trial an increase in survival in advanced NSCLC patients. Tarceva will be available within five shipping days.

"The FDA approval of erlotinib marks an important new treatment option for patients in the United States with advanced non-small cell lung cancer after chemotherapy has failed," said Alan Sandler, M.D., associate professor of medicine at Vanderbilt University and medical director of the Thoracic Oncology Department. "Physicians will now be able to offer patients a new therapy that has been proven to increase survival and that is different from traditional cytotoxic chemotherapy treatment."

The FDA based its approval decision for Tarceva on results from a randomized double-blind, placebo-controlled pivotal Phase III trial of patients with second and third-line advanced NSCLC. In this pivotal study, patients receiving Tarceva had a median survival of 6.7 months compared to 4.7 months in patients who received placebo (a 42.5 percent improvement). A hazard ratio (HR) of 0.73 and a p-value of less than 0.001 were determined for comparisons of overall survival (HR of less than one indicates a reduction in the risk of death and a p-value of less than 0.05 indicates statistical significance). In addition, 31.2 percent of patients receiving Tarceva in the study were alive at one year versus 21.5 percent in the placebo arm.

Results from two earlier large, randomized, placebo-controlled clinical trials in first-line advanced NSCLC patients showed no clinical benefit with concurrent administration of Tarceva with doublet platinum-based chemotherapy (carboplatin and paclitaxel or gemcitabine and cisplatin) and its use is not recommended in that setting.

In the pivotal trial, the most common adverse reactions in patients receiving Tarceva were rash and diarrhea. Grade three/four rash and diarrhea occurred in nine and six percent of Tarceva-treated patients, respectively. Rash and diarrhea each resulted in discontinuation of one percent of Tarceva-treated patients. Six and one percent of patients needed dose reduction for rash and diarrhea, respectively. Historically, there have been infrequent reports of serious interstitial lung disease (ILD), including fatalities, in patients receiving Tarceva for treatment of NSCLC or other advanced solid tumors. In the Phase III trial, severe pulmonary reactions, including potential cases of interstitial lung disease, were infrequent (0.8 percent) and were equally distributed between treatment arms. The overall incidence of ILD in Tarceva-treated patients from all studies was approximately 0.6 percent.

"This is a significant day for non-small cell lung cancer patients and their families," stated Colin Goddard, Ph.D., Chief Executive Officer of OSI Pharmaceuticals. "Tarceva offers a new kind of therapy for advanced lung cancer patients, not only providing improved survival, but doing so without many of the side effects associated with conventional chemotherapy."

"The FDA approval of Tarceva is the result of extraordinary effort and commitment by many employees at OSI and Genentech, clinical investigators, the FDA, and most importantly, the patients who volunteered to be part of the clinical trial that resulted in this approval," said Arthur D. Levinson, Ph.D., Genentech's chairman and chief executive officer.

Genentech does not expect Tarceva's approval specifically to affect its previously stated expectation of non-GAAP earnings of $0.80 to $0.83 for 2004.

The Tarceva NDA was granted Pilot 1 Status under the FDA's Pilot 1 Program for Continuous Marketing Applications, a new program designed for investigational products that have been given Fast Track status, such as Tarceva, and that have demonstrated significant promise in clinical trials as a therapeutic advance over available therapy for a disease or condition. Under Pilot 1 status, the FDA is committed to reviewing each unit of the NDA within six months of each unit submission. Tarceva is one of the first drugs to be granted and approved under the FDA's Pilot 1 program.

The pivotal trial for Tarceva included 731 patients with advanced NSCLC for whom one or more chemotherapy regimens had failed. The primary endpoint for the study was survival. In addition to achieving this primary endpoint, Tarceva also met all secondary endpoints of the trial. The global study was conducted by the National Cancer Institute of Canada Clinical Trials Group based at Queen's University in collaboration with OSI Pharmaceuticals.

According to the World Health Organization, there are more than 1.2 million cases worldwide of lung and bronchial cancer each year, causing approximately 1.1 million deaths annually. It is estimated that more than 173,000 people will be diagnosed with lung cancer in the United States in 2004. According to the National Cancer Institute, lung cancer is the single largest cause of cancer deaths in the United States and is responsible for nearly 30 percent of cancer deaths in this country. NSCLC is the most common form of the disease and accounts for almost 80 percent of all lung cancers. "When chemotherapy fails patients with advanced non-small cell lung cancer, they often feel like they are running out of options. Today, with the approval of Tarceva, patients not only have another option, but one that extends survival. That is something lung cancer patients don't often get offered," said Jane Reese-Coulbourne, acting executive director, ALCASE (Alliance for Lung Cancer Advocacy, Support and Education).

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