Swiss drugmaker Roche has officially asked the European Commission’s Committee for Medicinal Products for Human Use (CHMP) to re-evaluate its application for Tarceva in pancreatic cancer, which was rejected in late July.
Tarceva (erlotinib) is already on the market for non-small cell lung cancer in Europe, and both NSCLC and pancreatic cancer in the USA. The US approval is based on the same dataset as was reviewed by the European panel.
But the CHMP issued a negative opinion on its first-line use in pancreatic cancer alongside Eli Lilly’s Gemzar (gemcitabine), saying that the regimen had a ‘very limited’ impact on survival that did not outweigh an increase in side effects compared to Gemzar used alone.
That ruling was a blow to Roche, which sees Tarceva as a major new growth driver for its oncology franchise alongside blockbuster colorectal cancer drug Avastin (bevacizumab). Tarceva achieved sales of 367 million Swiss francs in the first half of this year, only just short of its entire turnover in 2005.
In a statement released this morning, Roche said that people with pancreatic cancer have limited treatment options and Tarceva is the first treatment for many years to have shown a significant survival benefit in this setting.
"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 at Roche. "In light of this, we are asking the CHMP to re-consider its opinion."
Trials are also being conducted with Tarceva in other solid tumours, such as ovarian, colorectal, head and neck and brain cancers.