The European Committee for Medicinal Products for Human Use (CHMP) has responded unenthusiastically, despite Tarceva being the first treatment for many years to have shown significant survival benefits in patients with pancreatic cancer.
“People with pancreatic cancer need new treatment options like Tarceva which has been proven in clinical trials to significantly increase survival and has already been approved for this indication in the US,” said Eduard Holdener, Head of Global Drug Development. “In light of this, we are asking the CHMP to re-consider its opinion.”
Tarceva was granted a licence by the American FDA in November 2005 for the first-line treatment of patients with locally advanced pancreatic cancer in combination with chemotherapy. Both the US and the EU license applications are based on data from the phase III study which showed that treatment with Tarceva plus chemotherapy results in significantly longer survival compared to the chemotherapy treatment alone.
24% of patients receiving Tarceva plus chemotherapy were alive after one year, compared to 19% on chemotherapy alone.
Tarceva is also approved and marketed in the US and across the European Union for patients with locally advanced non-small cell lung cancer.
Pancreatic cancer is one of the most aggressive forms of cancer killing more people within the first year of diagnosis than any other cancer.