Roche files Tarceva for first-line lung cancer use

Swiss drugmaker Roche Holding AG said on Thursday it had submitted its Tarceva drug to the European Medicines Agency for use as a first-line treatment for patients with advanced non-small-cell lung cancer.

Roche, the world’s largest maker of cancer drugs, said in a statement that OSI Pharmaceuticals, with whom it co-markets Tarceva, filed a parallel application with the U.S. Food and Drug Administration for use immediately after initial treatment with platinum-based chemotherapy.

Roche stock was down 0.4 percent at 114.30 Swiss francs at 1125 GMT, outperforming the European healthcare sector index, which was down 2.3 percent.

“The evidence that Tarceva is effective in most treatment alternatives of advanced non-small cell lung cancer supports our peak sales expectation of 2 billion francs,” said Vontobel analyst Andrew Weiss, who expects U.S. and EU authorities to respond to the applications early next year.

Roche said the EU and U.S. filings were based on data from a phase III study announced in November that showed that treatment with Tarceva, or erlotinib, delayed the progression of non-small-cell lung cancer when given immediately following chemotherapy.

The drug is already approved for use against pancreatic cancer and for patients with locally advanced or metastatic non-small-cell lung cancer.

Tarceva, which is relatively unusual among cancer treatments in that it is given by mouth rather than injection, is one of a new generation of targeted drugs that attack only cancer cells and are tolerated better than traditional chemotherapy.

ZURICH (Reuters)