Pancreatic Cancer
FDA Approves Tarceva for Advanced Pancreatic Cancer
Nov 8, 2005 - 4:28:38 PM

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 (1).

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.

"Pancreatic cancer is a devastating disease, and with Tarceva patients will receive a treatment which offers survival benefits," said William M. Burns, CEO Division Roche Pharma. "We are pleased by the decision from the FDA and are committed to work with health authorities to make Tarceva available to patients elsewhere."

Pancreatic cancer is the fifth leading cause of cancer deaths in the developed world (2) and is the tenth most frequently occurring cancer in Europe (3) with a death rate of approximately 78,000 people per year (4). Pancreatic cancer is difficult to treat, as it is often resistant to chemotherapy and radiotherapy, and tends to spread quickly to other parts of the body, leading to its high mortality and short life expectancy.

"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," 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. "Erlotinib represents a notable step forward for patients and healthcare providers in a disease with a very poor prognosis."

Phase III Studies Show Clear Advantages for Tarceva

Both the FDA approval and EU filing for Tarceva in pancreatic cancer are based upon the results of the pivotal Phase III randomised study (PA3)1 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 results of PA31 demonstrated the following:

- Treatment with Tarceva plus gemcitabine in patients with advanced pancreatic cancer resulted in significantly longer survival compared to gemcitabine alone (23%)

- 24% of patients receiving Tarceva plus gemcitabine were alive after one year, compared to 19% on gemcitabine alone

- Patients receiving Tarceva plus gemcitabine experienced significantly longer progression-free survival

- Tarceva plus gemcitabine was well tolerated by patients with no increase in haematological toxicity; Rash and diarrhoea were the principal Tarceva-related side effects seen in the study and were generally characterised as mild-to-moderate

- Tarceva plus gemcitabine reported a safety profile generally consistent with that seen in other studies both monotherapy and combination settings

The FDA has approved Tarceva plus gemcitabine chemotherapy for the treatment of locally advanced, inoperable or metastatic pancreatic cancer.

About Tarceva

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. Additionally, Tarceva is being studied in combination with Avastin in NSCLC. Trials are also being conducted with Tarceva in other solid tumours, such as ovarian, bronchioloalveolar (BAC), colorectal, pancreatic, head and neck and glioma (brain). Chugai is pursuing its development and regulatory approval for the Japanese market.

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