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Roche Gets EC Nod for Tarceva as First-Line Therapy in EGFR-mutated NSCLC; Awaits CE Mark for CDx

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This article was originally posted on Sept. 1.

Roche last week said that the European Commission has approved the use of Tarceva as a first-line monotherapy for non-small cell lung cancer in patients with EGFR activating mutations.

Roche's diagnostic arm is developing a companion test to identify EGFR-mutation-positive patients for the drug. The company said it expects the CE Mark for the Cobas EGFR Mutation Test before the end of the year.

Tarceva is already approved in Europe for use in advanced or metastatic NSCLC as a second- and third-line therapy regardless of patients' EGFR status. The approval for the expanded indication follows a late July recommendation from the European Medicines Agency's Committee for Medicinal Products for Human Use (PGx 7/27/2011).

Tarceva (erlotinib) is marketed by Roche subsidiary Genentech and Astellas.

"The European approval for Tarceva is good news for patients with a genetically distinct form of lung cancer because these patients may derive greater benefit when the medicine is used as an initial treatment," Hal Barron, chief medical officer and head of global product development at Roche, said in a statement.

Roche noted that there are around 1.6 million new cases of lung cancer diagnosed annually, while around 1.3 million people die each year as a result of the disease. The company estimates that between 10 percent and 30 percent of patients with NSCLC have tumors with EGFR activating mutations. Approximately 400,000 NSCLC patients, with and without EGFR activating mutations, are using Tarceva for its current indication as a second- and third-line treatment.

Tarceva sales in 2010 were 1.3 billion Swiss francs ($1.6 billion), including the drug's indications in lung and pancreatic cancer.

The EC approval is based on data from the European Randomized Trial of Tarceva vs. Chemotherapy study led by the Spanish Lung Cancer Group in cooperation with Roche. The phase III study showed that Tarceva nearly doubled median progression-free survival in EGFR-mutation-positive NSCLC patients and more than tripled the response rate compared to chemotherapy. The investigators presented data on the EURTAC study at the American Society of Clinical Oncology's annual meeting in June (PGx Reporter 6/8/2011).

Roche is currently in discussions with the US Food and Drug Administration to similarly expand Tarceva's use into the EGFR-mutated NSCLC population for first-line use. The company next year expects to file a supplemental new drug application with the FDA using data from the EURTAC study. Simultaneously, Roche will file a premarket approval application for the Cobas EGFR companion test in the US.

Tarceva is currently approved in the US as a maintenance treatment for patients with advanced-stage NSCLC that has not progressed after initial treatment with chemotherapy. It is also indicated in the second- and third-line setting to treat advanced NSCLC that has spread after receiving one chemotherapy regimen.

Roche has said that it plans to submit efficacy and cost-effectiveness analysis for Tarceva in the EGFR-mutated NSCLC population to the UK's National Institute for Health and Clinical Excellence in mid-October. NICE's final recommendation on whether UK's National Health Service should pay for the drug in this patient subset is slated for mid-2012.

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