Roche and Genentech have filed for approval of Avastin in the USA for the treatment of non-small cell lung cancer, on the back of data that show the drug is the first in more than a decade to show a survival benefit in NSCLC patients.

The license application is asking for the go-ahead to use Avastin (bevacizumab) in combination with a platinum-based chemotherapy (carboplatin plus paclitaxel) for previously untreated patients suffering from advanced non-squamous NSCLC, which accounts for 87% of all lung cancers cases in the USA.

Avastin is already approved in the USA and Europe for colorectal cancer, and pulled in sales of 1.7 billion Swiss francs ($1.3 billion) for Roche in 2005 - its first full year on the market.

Last year, the two companies reported that previously untreated NSCLC patients who received Avastin in addition to standard chemotherapy had an average overall survival of 12.5 months, compared to 10.2 months for those receiving standard chemotherapy alone.

In spite of chemotherapy, less than 5% of advanced NSCLC patients survive for five years and most die within twelve months.

Roche said today it has also started a further study, the AVAiL trial, which is exploring the combination of Avastin with another platinum- based chemotherapy (cisplatin/gemcitabine). Interim data from this study will be used together with the earlier data to file Avastin with the European health authorities later this year.

Avastin, one of the fastest growing of Roche's top-five sellers, was the first drug to be approved in a new class of cancer agents that work by inhibiting the formation of blood vessels to the tumour. It has been referred to by many as "a pipeline in a product," due to its potential application across a spectrum of tumour types.

Avastin is also due to be filed for approval in breast cancer during this quarter and, if the green light for both these new uses is granted, the product’s already strong turnover could see a substantial boost.