Decision comes less than two weeks after FDA approval in the same setting.

OSI Pharmaceuticals and Roche report obtaining European Commission approval for Tarceva® as a monotherapy maintenance treatment in patients with advanced non-small-cell lung cancer (NSCLC) whose disease remains largely unchanged after platinum-based initial chemotherapy.

European sanction comes less than two weeks after FDA approval of Tarceva as a maintenance therapy. On April 16, the agency okayed the drug for patients with locally advanced or metastatic NSCLC that had not progressed after four cycles of platinum-based first-line chemotherapy. Tarceva is now approved in 109 countries for advanced NSCLC and 80 countries for pancreatic cancer, according to OSI and Roche.

“We are pleased that the European health authorities recognize Tarceva as a valuable option for lung cancer patients and their physicians when used in the first-line maintenance setting,” says Colin Goddard, Ph.D., CEO of OSI Pharmaceuticals. “We look forward to working with our partner, Roche, to advance the robust Tarceva life cycle program, which includes evaluating Tarceva in the adjuvant setting and as a first-line treatment for advanced NSCLC patients with an activating EGFR mutation as well as branching into other disease settings including liver cancer.”

EU approval was based on data from the Phase III Saturn study, an international, placebo-controlled, randomized, double-blinded trial that enrolled 889 patients with advanced NSCLC at approximately 160 sites worldwide. Patients were treated with four cycles of standard first-line platinum-based chemotherapy and then randomized to Tarceva or placebo if the cancer did not progress.

The trial showed that Tarceva given as a maintenance therapy immediately after first-line chemotherapy extended overall survival and improved progression-free survival in a broad patient population including squamous and nonsquamous histology compared with placebo.

Roche reported global sales of Tarceva reached CHF 1.3 billion in 2009 (about $1.22 billion), up 10% on 2008 and represented 3% of the firm’s overall global sales. In 2009, the drug was Roche’s eighth biggest selling pharmaceutical.

OSI says that its Tarceva-related revenues reached $359 million in 2009 compared with $335 million in 2008. The 2009 figure included Tarceva-related royalties of $146 million from Roche. Royalty revenues in 2009 were based on Tarceva net sales in the rest of the world of approximately $724 million.

Tarceva is a once-daily pill that targets the EGFR pathway. It is designed to inhibit the tyrosine kinase activity of the EGFR signaling pathway inside the cancer cell.

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