EU approves Avastin (bevacizumab) + Tarceva (erlotinib) for metastatic or recurrent non-squamous non-small cell lung cancer with EGFR mutation- Roche

Roche announced that the European Commission has approved the use of Avastin (bevacizumab) in combination with Tarceva (erlotinib) for the first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC) with Epidermal Growth Factor Receptor (EGFR)-activating mutations.The pivotal phase II JO25567 study showed a statistically significant 46 percent relative reduction in the risk of disease progression or death (median PFS: 16.0 months versus 9.7 months) for people treated with the combination of Avastin plus Tarceva compared to Tarceva alone.

Avastin and Tarceva each target pathways which are known to be key drivers in the development and growth of tumours. The beneficial effect of Avastin plus Tarceva is supported by results of other clinical studies which showed the combination was effective and tolerable. No new and clinically significant adverse events were observed and the toxicity profile was shown to be managable.

Comment: Approximately 10-15 percent of Europeans with NSCLC will have tumours with EGFR-activating mutations, representing an estimated 33,000 cases in Europe per year.