Roche’s Avastin has received yet another approval, this time from regulators in the European Union for the first-line treatment of patients with advanced lung cancer.
Having received a positive recommendation from the Committee for Medicinal Products for Human Use last month, the European Union has now given the go-ahead to market Avastin (bevacizumab) for the first-line treatment of patients with advanced non-small cell lung cancer in combination with platinum-based chemotherapy. The approval is based on data from the Phase III E4599 trial in the USA and the ‘Avastin in Lung’ (AVAiL) late-stage study, is for the use of Avastin at a dose of 7.5 or 15 mg/kg.
Roche noted that Avastin, an anti-angiogenic agent, is the only first-line therapy to demonstrate improved survival benefits beyond one year in patients with advanced NSCLC and Christian Manegold, professor of medicine at Heidelberg University, and principal investigator of the AVAiL study, sang its praises. He said that 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 “that breaks through the one-year survival barrier is a big step forward,” he added, and this European approval “means we can reassess our expectations for lung cancer patient survival”.
This latest piece of good news for Roche means that Avastin sales, which brought 1.9 billion Swiss francs (around $1.6 billion; up 40%) during the first half of the year, can only go higher. In Europe, Avastin was first approved in January 2005 (and in the USA in February 2004) for first-line treatment of patients with metastatic colorectal cancer. It received another approval in the USA in June 2006 it was then given the green light by the US Food and Drug Administration for the treatment of NSCLC in October 2006, following priority review.
Most recently, in March 2007, Avastin was approved in Europe for the first-line treatment of women with metastatic breast cancer and in April in Japan for use in advanced or recurrent colorectal cancer. Roche and Genentech are also exploring its use in pancreatic and ovarian cancer, among others.