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FDA expands use of Roche/ Astellas’ Tarceva in lung cancer patients

New indication approved alongside companion diagnostic to detect gene mutation

FDA expands use of Roche/ Astellas' Tarceva in lung cancer patients

More patients with lung cancer in the US will have access to Roche/ Astellas' oncology medicine Tarceva after the FDA approved an expanded indication for the drug alongside a companion diagnostic to detect patients suitable for treatment.

The US regulator yesterday backed Tarceva (erlotinib) as a first-line treatment of people with metastatic non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) activating mutations.

The decision is based on a related approval for by Roche's cobas EGFR Mutation Test, which can detect the EGFR mutations thought to occur in about 10 per cent of people with NSCLC.

“The approval of the cobas EGFR Mutation Test will allow physicians to identify non-small cell lung cancer patients who are candidates for receiving Tarceva as first line therapy,” said Dr Alberto Gutierrez, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA's Center for Devices and Radiological Health.

Tarceva has already demonstrated that it can extended progression-free survival in patients with the EGFR mutation compared to placebo, and its approval further reveals the growing importance of personalised medicines (also known as stratified medicines).

Paul Brown, head of Roche Molecular Diagnostics, commented on the related need for diagnostics to ensure these medicines are targeted at the right patient.

“Increasingly, doctors and patients rely on diagnostics to help guide personalised treatment decisions,” he said.

“The approval of the cobas EGFR Mutation Test highlights the importance of sensitive, accurate tests that can be conducted in time to inform crucial treatment decisions.”

Tarceva is already available in several later-stage non-personalised indications in the US, including as a treatment for people with advanced-stage NSCLC whose cancer has not spread or grown after initial treatment with certain types of chemotherapy, and for patients with advanced-stage NSCLC whose cancer has spread or grown after receiving at least one chemotherapy regimen.

It is jointly marketed by Astellas and Roche's Genentech unit in the US and by Roche in Europe.

15th May 2013

From: Sales



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