Avastin approved in Europe for advanced lung cancer

Aug 26 2007

Avastin (bevacizumab), Roche's innovative anti-cancer drug, was approved today in Europe for the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC), in combination with platinum-based chemotherapy.

NSCLC is the most common form of lung cancer, a difficult to treat disease that kills over 3,000 people per day worldwide. NSCLC is usually diagnosed at an advanced stage, meaning individuals diagnosed with the disease typically have a life expectancy of only 8 to 10 months. Avastin is the only first-line therapy to demonstrate improved survival benefits beyond one year in patients with advanced NSCLC.

The approval is based on data from the pivotal US phase III trial (E4599) and the 'Avastin in Lung' (AVAiL) phase III trial. Both studies demonstrate that Avastin is effective for the treatment of patients with NSCLC in combination with platinum-based chemotherapy. The approval is for the use of Avastin at a dose of 7.5 or 15 mg/kg, in combination with platinum-based chemotherapy, for the first-line treatment of patients with unresectable advanced, metastatic or recurrent NSCLC other than predominantly squamous cell histology. The broad label that Avastin has received for the treatment of NSCLC allows the combination of Avastin with any platinum-based chemotherapy regimens (for example, together with taxanes or gemcitabine) at the choice of the physician.

Professor Christian Manegold, Professor of Medicine at Heidelberg University, University Medical Center Mannheim, Germany and Principal Investigator of the AVAiL trial, was enthusiastic about the news: "Lung cancer is an extremely difficult disease to treat and Avastin has proven that it can prolong the life of patients with NSCLC. A treatment like Avastin that breaks through the one year survival barrier is a big step forward. The European approval for Avastin means we can reassess our expectations for lung cancer patient survival."

Avastin is the first and only anti-angiogenic agent which has been shown to consistently deliver improved overall and/or progression-free survival for patients with colorectal, lung, breast and kidney cancer.

The results of the randomised, controlled, multicentre phase III E4599 study of 878 patients with locally advanced, metastatic or recurrent NSCLC, with histology other than predominant squamous cell, show that median survival of patients treated with Avastin at a dose of 15 mg/kg every three weeks plus chemotherapy was 1.3 months, compared to 10.3 months for patients treated with chemotherapy alone. Patients receiving Avastin in combination with paclitaxel and carboplatin had a 5% improvement in overall survival compared to patients who received chemotherapy alone. Side effects were generally manageable. Pulmonary haemorrhage/ haemoptysis cases were observed in .3% of the patients receiving Avastin plus chemotherapy. The most common adverse events associated with Avastin therapy were: hypertension (5.6%), proteinuria (4.%), fatigue (5.1%) and dyspnoea (5.6%).

In the double-blind, randomised, controlled, phase III AVAiL study, patients received treatment with either Avastin at 7.5mg/kg or 15mg/kg + cisplatin/gemcitabine or placebo + cisplatin/gemcitabine. The study involved more than 1,000 patients world-wide with previously untreated advanced NSCLC, with histology other than predominant squamous cell. The results show that by adding Avastin to a cisplatin/gemcitabine regimen progression-free survival was significantly prolonged by 0 to 30% compared with chemotherapy alone. No new or unexpected adverse events were observed.