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Tarceva wins Japanese approval for lung cancer patients

Roche and OSI Pharmaceuticals win Japanese approval for Tarceva for the treatment of patients with non-resectable, recurrent and advanced non-small cell lung cancer aggravated by chemotherapy

Roche and OSI Pharmaceuticals have won approval from the Japanese Ministry of Health, Labour and Welfare for Tarceva (erlotinib) for the treatment of patients with non-resectable, recurrent and advanced non-small cell lung cancer (NSCLC) aggravated by chemotherapy.

Tarceva has been demonstrated to increase overall survival and offer an improvement in quality of life. NSCLC is the most common form of lung cancer and is more deadly than colon, breast, and prostate cancers combined. In 2005, the number of newly diagnosed patients with NSCLC in Japan reached 85,000.

Tarceva's approval in Japan is based on the submission of two phase II studies which confirmed the safety and efficacy of Tarceva in Japanese patients, along with data from a randomised phase III study which compared Tarceva with a placebo in patients with advanced NSCLC after failure of at least one prior chemotherapy regimen.

Thirty-one per cent of patients treated with Tarceva were alive at one year, compared with 22 per cent in the placebo arm. Patients in the BR.21 study also experienced a 42.5 per cent improvement in the length of overall survival (6.7 months, compared with 4.7 months). More patients on the drug had improvement in cough, pain, shortness of breath and overall physical function, compared with a placebo.

The BR.21 study, which was also published in the New England Journal of Medicine (NEJM), has accelerated Tarceva's approval in over 80 countries for the treatment of patients with locally advanced or metastatic NSCLC after failure of at least one prior chemotherapy regimen.

Chugai, Roche's Japan subsidiary, submitted the filing on 14 April 2006 to the Japanese Ministry of Health, Labour and Welfare. Following this formal approval, Tarceva is expected to launch in Japan by early 2008.

William M Burns, CEO of the Roche's pharmaceuticals division, said: "Tarceva has the proven ability to prolong survival and improve quality of life in patients with the most common and deadly form of lung cancer. This approval in Japan underscores our commitment to ensure that eligible patients around the world will have access to this effective treatment."

Total worldwide net sales of Tarceva for Q1 FY07 were approximately USD 198m, as reported by Genentech and Roche, representing a 48 per cent growth in global sales compared with global sales of USD 133 million in Q1 FY06.

30th September 2008

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