Roche's Avastin cleared for NSCLC in EU

Swiss drug major says that its anticancer drug Avastin (bevacizumab) has received European approval as a first-line treatment, in combination with chemotherapy, for patients with non-small cell lung cancer. Specifically, the drug has been approved at dosages of either 7.5mg/kg or 14mg/kg in advanced, metastatic or recurrent forms of the condition.

Approval is based on data from both the US E4599 study and the AVAiL trial (Marketletters passim), which demonstrated Avastin's efficacy against NSCLC when added to platinum-based chemotherapy, with treatment improving overall survival rates by around 25%. The data also showed that the progression-free survival duration was increased by 20-30% in those provided with Avastin plus chemotherapy, compared with patients who received chemotherapy alone.

Roche welcomed the decision, noting that the drug is the only first-line therapy of its type to have demonstrated survival benefits beyond one year in those suffering from the disease. The drug is also approved, in both Europe and the USA, for the first-line treatment of patients with advanced colorectal cancer, receiving additional US clearance as a second-line therapy for this indication last year (Marketletters passim).