Roche and Genentech’s blockbuster agent Avastin has received approval for another indication in Europe, as a first-line treatment of women with metastatic breast cancer.
The European Commission has given the green light for Avastin (bevacizumab) in combination with a standard chemotherapy paclitaxel based on Phase III trial which show that women with metastatic breast cancer have the chance to live twice as long without their cancer progressing if treated with Avastin plus paclitaxel compared to taking the latter alone. The approval was based on a study called E2100 which saw 722 women randomised to receive treatment with paclitaxel with or without Avastin and those receiving the combination had a median progression-free survival (PFS) of more than a year (13.3 months). Patients receiving paclitaxel alone had a median PFS of 6.7 months. Overall in the trial, patients treated with Avastin plus paclitaxel had a 52% reduction in the risk of disease progression or death.
More than one million new cases of breast cancer are diagnosed worldwide every year, resulting in over 400,000 deaths per year and Roche noted that additional Phase III trials are ongoing to explore Avastin in the first-line treatment of the disease in combination with docetaxel and other commonly used chemotherapies including its own Xeloda (capecitabine). Recently, a Phase III first-line trial was initiated, called AVEREL, into HER2-positive breast cancer evaluating Avastin in combination with docetaxel plus Herceptin (trastuzumab).
The EU’s green-light is the latest in a number of approvals Avastin has achieved and Roche noted that it is “the first and only anti-angiogenic agent which has been shown to consistently deliver improved overall and/or progression-free survival benefit for colorectal, lung, breast and renal cell cancer patients.” In Europe, Avastin was approved in January 2005 and in the USA in February 2004 for first-line treatment of patients with metastatic colorectal cancer. It also got the green light from the US Food and Drug Administration last June as a second-line treatment for patients with advanced colorectal cancer and for the treatment of non-small cell lung cancer in October 2006.
Roche acquires 454 Life Sciences
Roche also announced that it has signed a definitive agreement to acquire 454 Life Sciences, a subsidiary of CuraGen Corp, which focuses on high-throughput DNA sequencing. Under the terms of the deal, Roche will pay $140 million in cash, and up to approximately $14.9 million from the exercise of stock options issued and outstanding prior to the acquisition.
454 Life Sciences and the Swiss-based have an existing research and marketing collaboration under which Roche Diagnostics is the exclusive worldwide distributor of the Genome Sequencer systems based on 454 Life Science’s ultrafast 454 Sequencing technology.