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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