Tarceva Cleared By Japanese Regulators For NSCLC

Tarceva (erlotinib) will launch in Japan in early 2008 after being approved by the Japanese Ministry of Health for the treatment of patients with nonresectable, recurrent and advanced non-small cell lung cancer aggravated following chemotherapy, Roche/OSI announced Oct. 22.

The approval will expand the treatment audience for Tarceva to a country that newly diagnosed 85,000 patients with NSCLC in 2005, according to the firms.

"Lung cancer patients in Japan will now have an important new treatment option which has been demonstrated to increase overall survival and offer an improvement in quality of life," the companies said.

The approval in Japan was based on two Phase II studies confirming the safety and efficacy of Tarceva in Japanese patients, along with data from the randomized Phase III study BR 21 comparing Tarceva to placebo in patients with NSCLC after failure of at least one prior chemotherapy regimen.

The epidermal growth factor receptor has been approved in over 80 countries, including the U.S. and European Union for the treatment of NSCLC. It also was approved in November 2005 in the U.S. and in January in Europe for the treatment of pancreatic cancer.

Roche's Japanese subsidiary Chugai submitted the filing for approval in Japan in April 2006. In the U.S., OSI is partnered on Tarceva with Roche's Genentech. Roche reported global sales of Tarceva Oct. 16 for the first nine months of the year of CHF 774million ($657.5 million), up 34 percent, driven by ex-U.S. sales.

-Jessica Merrill

This article is reprinted from "The Pink Sheet" DAILY – Oct. 23, 2007

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