OSI Pharmaceuticals/Roche: Tarceva Faces Competition in Japan

OSI Pharmaceuticals and Roche have said that their drug Tarceva has been approved in Japan in the treatment of non-small cell lung cancer. However, Tarceva is set to face stiff competition from AstraZeneca’s Iressa, which is also a small molecule EGFR inhibitor that was initially approved for the same indication in 2002.

OSI Pharmaceuticals and Roche have announced that the Japanese Ministry of Health, Labor and Welfare has granted approval to Tarceva (erlotinib) for the treatment of non-resectable, recurrent and advanced non-small cell lung cancer (NSCLC) which is aggravated following chemotherapy, on the basis of positive results from two Phase II studies showing its efficacy and safety in Japanese patients, along with data from the pivotal Phase III BR.21 study.

Chugai, Roche’s alliance partner in Japan, initially filed for approval of Tarceva in April 2006. The basis for approval were results from two Phase II clinical trials that confirmed the safety and efficacy of Tarceva in Japanese patients, as well as data from the Phase III BR.21 study, which formed the basis for approval in the US and EU. The BR.21 study showed that Tarceva administered to advanced NSCLC patients following the failure of one prior chemotherapy regimen improved overall survival by 42.5% in comparison with placebo. In addition, the one-year survival rate associated with Tarceva was 31% versus 22% for placebo.

As a result of the approval, Chugai expects to launch Tarceva in Japan in early 2008. NSCLC is traditionally associated with very high levels of unmet need, and is the leading cause of cancer-related death in both men and women, therefore the approval of Tarceva represents a valuable breakthrough for the treatment of NSCLC in Japan.

Despite this, Tarceva is set to face stiff competition from AstraZeneca’s Iressa (gefitinib), which like Tarceva, is also a small molecule epidermal growth factor receptor (EGFR) inhibitor. Iressa was initially approved for the treatment of NSCLC in Japan in 2002; however, its failure to confer a survival benefit in Phase III studies meant it had its European marketing authorization application withdrawn and its US label revised so as to severely restrict use. However, ethnic differences in NSCLC mean that Iressa is effective in Japanese patients and has therefore become an established therapy in this indication.