Roche to trial Tarceva in EGFR lung cancer

27 April 2009

Swiss drug major Roche is to collaborate with the Spanish Lung Cancer Group on the first Phase III trial to investigate Tarceva (erlotinib) in  lung cancer patients with genetic mutations in their epidermal growth  factor receptor.

The EURTAC study is the first prospective, randomized Phase III trial to  investigate whether first-line treatment with Tarceva is superior to  chemotherapy in patients with EGFR mutation-positive disease. Tarceva  has already been shown to significantly extend survival and the time  people with advanced lung cancer live without their cancer getting worse  and without the side effects associated with chemotherapy. The results  from EURTAC, if positive, will support a submission by Roche to the  Eurpean Medicines Agency (EMEA) to seek an additional indication for the  use of Tarceva.

It has been shown that all patients who do not have the mutations  benefit from Tarceva, which has been approved in the USA since 2004.  Previous results from smaller trials suggest that tumors with mutations  are highly sensitive to treatment with Tarceva. As many as one in three  Asian patients with lung cancer have EGFR genetic mutations and they are  estimated to be present in 10% of people with lung cancer in the  population of the western hemisphere.

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