Purpose of application
In June 2011, an application was received from Roche Diagnostics Australia by the Department of Health and Ageing, requesting an MBS listing for genetic testing for mutations in the epidermal growth factor receptor (EGFR) gene in previously untreated locally advanced (stage IIIB) or metastatic (stage IV) non-small cell lung cancer (NSCLC) patients, to determine eligibility for first-line treatment with erlotinib. EGFR gene mutation testing is a co- dependent technology with the treatment of NSCLC with first-line erlotinib. Erlotinib, a tyrosine kinase inhibitor (TKI), has been previously approved by PBAC for use as a monotherapy for unselected NSCLC patients who have received prior platinum-based chemotherapy for NSCLC. In this application, it is being proposed as a first-line treatment for NSCLC patients with locally advanced or metastatic tumours who test positive for EGFR activating mutations. EGFR gene mutation testing has also been proposed as a marker for first-line treatment of NSCLC with the TKI gefitinib.
An independent evaluator group, as part of its contract with the Department of Health and
Ageing, has drafted an earlier version of this DAP.
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