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news.Roche, Chugai and OSI Pharmaceuticals have said that Tarceva has been approved in Japan for the treatment of patients with nonresectable, recurrent and advanced non-small cell lung cancer that is aggravated following chemotherapy.
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The Japanese Ministry of Health approval means that lung cancer patients in Japan will now have a new treatment option that has been demonstrated to increase overall survival and offer an improvement in the quality of life, Roche said.
Tarceva’s approval in Japan is based on the submission of two Phase II studies that confirmed the safety and efficacy of Tarceva in Japanese patients, along with data from the landmark, randomized, Phase III BR.21 study, which compared Tarceva to placebo in patients with advanced non-small cell lung cancer (NSCLC) after failure of at least one prior chemotherapy regimen.
William Burns, CEO of the pharmaceuticals division at Roche, said: “Tarceva (erlotinib) has proven to prolong survival and improve the quality of life of 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.”