The Swiss approval covers the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure of at least one prior chemotherapy regimen.
Tarceva (erlotinib) is an oral tablet indicated for daily administration. It is the only drug in the epidermal growth factor receptor (EGFR) class to demonstrate, in a phase III clinical trial, an increase in survival in advanced NSCLC patients.
As with the US label, Tarceva is indicated for all NSCLC patients after failure of at least one prior chemotherapy regimen and contains no restrictions on its use regarding EGFR status, mutation status, gender, smoking history, histology or ethnicity.
OSI was responsible for the US filing of Tarceva in advanced NSCLC, which received FDA approval in November 2004. In addition, a marketing authorization application was submitted by Roche to the European Health Authorities in August 2004.
“We would like to congratulate our colleagues at Roche on the first European approval of Tarceva,” stated Dr Colin Goddard, CEO of OSI. “We are pleased with the launch of Tarceva in the US to date and we continue to believe that Tarceva will emerge as a fundamentally important new agent in changing the paradigm for the treatment of cancer patients around the world.”