Switzerland’s Roche and US partner OSI Pharmaceuticals have won approval from the European Commission for Tarceva as a treatment for pancreatic cancer in combination with gemcitabine, a standard chemotherapy.
The green light for Tarceva (erlotinib), which was approved in the USA for this indication in November, was based on data from a Phase III which show that treatment with the drug plus gemcitabine results in significantly longer survival (25%) compared to the latter alone. In addition, a higher percentage of these patients were alive at 12 months in the group treated with Tarceva plus gemcitabine, compared to those treated with chemotherapy alone (21% versus 15%).
The approval comes just over a month after the European Medicines Agency did a U-turn on a decision made in July and voted to recommend Tarceva as a treatment for pancreatic cancer, after re-evaluating the data.
Pancreatic cancer has the highest one-year mortality rate of any form of the disease and is Europe's sixth-deadliest cancer, Roche noted. It 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 a short life expectancy.
Tarceva is also approved to treat non-small cell lung cancer and is currently being studied in combination with Avastin (bevacizumab) in that disease and in a wide variety of other solid tumour types.