Tarceva approval for first-line use in EGFR lung cancer
pharmafile | September 1, 2011 | News story | Sales and Marketing |Â Â NSCLC, Roche, TarcevaÂ
Tarceva has been granted final European approval for patients with a genetically distinct type of non-small cell lung cancer (NSCLC).
The European Commission approval means Tarceva (erlotinib) can be used as a first-line monotherapy in people with locally-advanced or metastatic NSCLC with EGFR (epidermal growth factor receptor) activating mutations.
Tumours with these mutations are responsive to Tarceva and its use has been shown to more than triple the number of patients whose tumours shrink (response rate). Tarceva has also shown to nearly double the time patients live without their disease progressing (progression free survival – PFS) compared to chemotherapy.
Tarceva is the biggest selling lung cancer drug, and earned 2010 sales of $1.6 billion (also including use in pancreatic cancer). It is already approved in Europe for use in advanced or metastatic NSCLC irrespective of a patient’s EGFR status. It is licensed both as maintenance therapy in patients with stable disease immediately after initial chemotherapy and in patients whose disease has progressed following at least one course of chemotherapy.
Its rival EGFR-targeting treatment, AstraZeneca’s Iressa (gefitinib) made far more modest sales of $393 million last year, largely because it is not approved in the US.
But until now Iressa has been the only lung cancer treatment to have first line approval in EGFR positive patients. It gained this approval in July 2009, but the new Tarceva approval now puts them on an equal footing.
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. It is estimated that 10-30% of patients with NSCLC have tumours with EGFR activating mutations.
A diagnostic for the EGFR mutations already exists, but Roche is also developing its own test. The company’s Molecular Systems division is developing the cobas EGFR Mutation Test, as a companion diagnostic for Tarceva to identify patients with EGFR mutations.
Andrew McConaghie
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