Tarceva (erlotinib), the only EGFR-inhibitor to have shown a survival benefit in lung cancer, will now benefit patients with advanced pancreatic cancer following FDA approval in the United States. Pancreatic cancer is one of the most aggressive forms of the disease and kills more people within the first year than any other cancer. Tarceva is the first new treatment in a decade that has shown a significant improvement in overall survival (23%) when added to chemotherapy.
Earlier in October, Roche submitted a marketing authorisation application to the European health authorities for Tarceva to be used in combination with gemcitabine chemotherapy for the first-line treatment of patients with advanced pancreatic cancer, informs a company release.
"Pancreatic cancer is a devastating disease, and with Tarceva patients will receive a treatment which offers survival benefits. We are pleased by the decision from the FDA and are committed to work with health authorities to make Tarceva available to patients elsewhere." said William M. Burns, CEO division Roche Pharma.
"Improvements in therapy in advanced pancreatic cancer have been very difficult to come by. As a molecularly targeted agent, erlotinib has been shown to add a survival benefit when combined with gemcitabine for patients facing pancreatic cancer. Erlotinib represents a notable step forward for patients and healthcare providers in a disease with a very poor prognosis," said Dr. Malcolm Moore, study chair and medical oncologist at Princess Margaret Hospital in Toronto, Canada, and chair of the gastrointestinal disease site, NCIC clinical trials group.
The release further added that both the FDA approval and EU filing for Tarceva in pancreatic cancer are based upon the results of the pivotal Phase III randomised study of 569 patients conducted by the National Cancer Institute of Canada clinical trials group based at Queen's University. The double blind study evaluated Tarceva's efficacy in patients with locally advanced or metastatic pancreatic cancer.
The FDA has approved Tarceva plus gemcitabine chemotherapy for the treatment of locally advanced, inoperable or metastatic pancreatic cancer.
Tarceva is a small molecule that targets the human epidermal growth factor receptor (HER1) pathway. HER1, also known as EGFR, is a key component of this signalling pathway, which plays a role in the formation and growth of numerous cancers. Tarceva blocks tumour cell growth by inhibiting the tyrosine kinase activity of the HER1 signalling pathway inside the cell.
Tarceva is also approved in the US and across the European Union for patients with locally advanced or metastatic non small cell lung cancer (NSCLC) after failure of at least one prior chemotherapy regimen. Tarceva is currently being evaluated in an extensive clinical development programme by a global alliance among OSI Pharmaceuticals, Genentech, and Roche, focussing on earlier stages of NSCLC.
Pancreatic cancer is the fifth leading cause of cancer deaths in the developed world and is the tenth most frequently occurring cancer in Europe with a death rate of approximately 78,000 people per year.