Another win for Roche’s anticancer drug Avastin (bevacizumab) last week after Europe’s advisory panel, the Committee for Medicinal Products for Human Use, issued a positive recommendation for its use as a first-line treatment for the most common form of lung cancer - non-small cell lung cancer.
The thumbs-up was based on data from the Phase III E4599 study of 878 NSCLC patients, which found median survival in those given Avastin every three weeks plus chemotherapy was 12.3 months, compared to 10.3 months for patients treated with chemotherapy alone. And, amongst patients given Avastin plus paclitaxel and carboplatin, survival was boosted 25% compared to patients who received chemotherapy alone.
Similarly, the AVAiL trial compared Avastin plus cisplatin/gemcitabine or placebo plus cisplatin/gemcitabine in previously-untreated NSCLC patients. Adding Avastin to the regimen significantly prolonged survival by 20%-30%.
Lung cancer is responsible for over 3,000 deaths per day worldwide and NSCLC accounts for more than 80% of this figure, says Roche. Avastin is an anti-angiogenic agent and the only first-line treatment in over a decade that has been shown to extend survival in previously untreated patients with NSCLC beyond one year.
Said Professor Christian Manegold, Professor of Medicine, Heidelberg University, University Medical Center, Mannheim, Germany and Principal Investigator of the AVAiL study: "I believe that Avastin is such an innovative treatment that it will change not only the current standard of care in NSCLC, but it will also re-write our expectations for patient outcomes."
More approvals on the horizon?
Certainly Avastin is one of Roche’s most promising drugs, bringing it 1.9 billion Swiss francs ($1.6 billion; up 40%) during the first half of the year. It was first approved in the USA in 2004 and in Europe the year after for the first line colorectal cancer, an indication followed in the USA by a nod for second line treatment of advanced colorectal cancer and NSCLC. Most recently in April 2007, Avastin was approved in Europe for the first line treatment of women with metastatic breast cancer and in Japan for use in advanced or recurrent colorectal cancer, where it started its roll-out in June. Roche and Genentech are also exploring its use in pancreatic cancer, ovarian cancer, renal cell carcinoma, with the total development programme expected to include over 40,000 patients worldwide.
Roche sought European approval in April to expand the product’s marketing approval in advanced colorectal cancer to include combinations with chemotherapy regimens based on oxaliplatin. Also in April Roche applied for EU marketing approval for Avastin in the first-line treatment of advanced renal cell carcinoma, the most common type of kidney cancer.
Lung cancer is the second biggest cancer killer in Europe. Less than 5% of people with advanced NSCLC survive for five years after diagnosis and most die within twelve months.