Roche announced that following the US FDA approval in the US, Avastin will now benefit patients suffering from advanced non-small cell lung cancer (NSCLC) the most common form of this devastating disease. The approval is based on the pivotal phase III trial data (E4599) which showed a strong survival benefit for patients treated with Avastin in combination with a platinum-based chemotherapy (carboplatin plus paclitaxel) compared to chemotherapy alone.
"Avastin is the first therapy ever to extend survival for advanced lung cancer patients beyond one year," said Eduard Holdener, Head Global Pharma Development at Roche. "The FDA approval marks a significant step forward for lung cancer patients in the US. We are committed to working with regulatory authorities around the world in order to make it available to more patients fighting this severe disease."
In the EU, Avastin in NSCLC was filed with health authorities in August this year. This application was based on the E4599 data along with preliminary data from the ongoing "Avastin in Lung" (BO17704) trial, which is exploring the combination of Avastin with another platinum-based chemotherapy (cisplatin/gemcitabine).
After colorectal and breast cancer, lung cancer is the third type of cancer in which the anti-angiogenic agent, Avastin, has demonstrated significant survival benefit. Avastin was approved in the EU in January 2005 and in the US in February 2004 for the first-line treatment of patients with metastatic colorectal cancer in combination with intravenous 5-FU-based chemotherapy. It received another approval in the US in June 2006 as a second-line treatment for patients with metastatic colorectal cancer in combination with intravenous 5-FU-based chemotherapy. The first filing for Avastin in Japan occurred in April 2006 for the treatment of advanced colorectal cancer. More recently, Avastin was filed for the treatment of women with advanced breast cancer in the EU in July 2006.
The FDA approval is based on results from the E4599 study; a randomised, controlled, multi-centre phase III trial. 878 patients with locally advanced, metastatic or recurrent NSCLC with histology other than predominant squamous cell were enrolled into the trial. The results showed:
Patients receiving Avastin at a dose of 15 mg/kg every three weeks plus paclitaxel and carboplatin had a 25 percent improvement in overall survival, compared to patients who received chemotherapy alone. Median survival was extended beyond one year for patients treated with Avastin (12.3 vs. 10.3 months).
Pulmonary haemorrhage (haemoptysis) cases were observed in 2.3 per cent of the patients receiving Avastin plus chemotherapy.
Avastin is the first treatment that inhibits angiogenesis - the growth of a network of blood vessels that supply nutrients and oxygen to cancerous tissues. Avastin targets a naturally occurring protein called VEGF (Vascular Endothelial Growth Factor), a key mediator of angiogenesis, thus choking off the blood supply that is essential for the growth of the tumour and its spread throughout the body (metastasis).
Roche and Genentech are pursuing a comprehensive clinical programme investigating the use of Avastin in various tumour types (including colorectal, breast, lung, pancreatic cancer, ovarian cancer, renal cell carcinoma and others) and different settings (advanced and adjuvant ie post-operation). The total development programme is expected to include over 40,000 patients worldwide.