Roche’s Lung cancer test approved for Europe
pharmafile | December 5, 2011 | News story | Research and Development, Sales and Marketing | Roche, Tarceva, lung cancer
A new test which should help to better target treatment of patients with non-small cell lung cancer (NSCLC) has received its CE mark in Europe and been approved for use.
Roche’s cobas EGFR Mutation Test, a companion diagnostic for the manufacturer’s lung cancer drug Tarceva (erlotinib), is designed to identify patients with EGFR (epidermal growth factor receptor) gene mutations.
Oral EGFR inhibitor Tarceva was approved by the European Commission in September as first-line monotherapy in people with locally advanced or metastatic NSCLC with EGFR activating mutations.
The biggest selling lung cancer drug, it earned sales of $1.6 billion last year, around four times more than its rival EGFR-targeting treatment, AstraZeneca’s Iressa (gefitinib).
It is estimated that up to a third of patients with NSCLC have tumours with EGFR activating mutations, and the new test will help personalise their therapy programmes by highlighting who may benefit from early treatment.
“Patients with this genetically distinct form of lung cancer derive great benefit when EGFR inhibitors are used as initial treatment,” said Daniel O’Day, chief of Roche Diagnostics.
In 2008, there were 1.6 million new cases of lung cancer, and each year 1.3 million people die as a result of the disease.
Treatment with EGFR inhibitors has been shown to more than triple the number of patients whose tumours shrink and to nearly double patients’ progression-free survival compared to chemotherapy.
Roche’s new test detects 41 mutations across four different exons of the EGFR gene from a single section of the patient’s tumour and delivers test results within eight hours.
It is the third oncology companion test the manufacturer has launched this year, following the cobas BRAF Mutation Test for metastatic melanoma and the cobas KRAS Mutation Test for advanced colorectal cancer.
These join existing methods for mutation detection, such as Sanger sequencing, on the market.
Adam Hill
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