Roche and Genentech have filed Avastin in the US for the treatment of the most common form of lung cancer - non-squamous non-small cell lung cancer. Lung cancer is the leading cause of cancer death worldwide.
The supplemental Biologics License Application (sBLA) has been submitted to the US Food and Drug Administration (FDA) for use of Avastin (bevacizumab) in combination with a platinum-based chemotherapy (carboplatin plus paclitaxel) for previously untreated patients suffering from advanced non-squamous non-small cell lung cancer (NSCLC). In the US, NSCLC accounts for 87 percent of all lung cancers cases.
Avastin is the first and only treatment in more than a decade to have shown a survival benefit in this patient population. The sBLA submission is based on Genentech's analysis of the results of the pivotal E4599 trial which were presented at ASCO last year.
"The filing of Avastin in the USA is a critical step forward. The benefits seen in the Avastin study are significant and we look forward to the potential of bringing new hope to the patients who are diagnosed with this specific type of lung cancer," Ed Holdener, Head of Roche Pharmaceuticals Development said adding, "We are committed to working with regulatory authorities around the world in order to make it available to patients suffering from lung cancer as soon as possible."
Roche has initiated 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 E4599 data to file a Marketing Authorisation Application (MAA) with the European health authorities later this year.
Lung cancer is the leading cause of cancer death worldwide, accounting for 1 in 3 and 1 in 4 cancer-related deaths in men and women, respectively. In the US, NSCLC accounts for 87 percent of all lung cancers. The majority of NSCLC cases are diagnosed at an advanced stage2 when the cancer is inoperable or has already spread to another part of the body. In spite of the use of chemotherapy as the first-line treatment option, less than five percent of advanced NSCLC patients survive for five years and most die within twelve months.
In Europe, Avastin was approved early 2005 for the first-line treatment of patients with metastatic carcinoma of the colon or rectum in combination with intravenous 5-fluorouracil/folinic acid or intravenous 5-fluorouracil/folinic acid/irinotecan. Avastin received approval by the US Food and Drug Administration (FDA) and was launched in the US in February 2004. Avastin is the first and only anti-angiogenic agent to have demonstrated improved survival in the three major causes of cancer death: colorectal cancer, NSCLC and breast cancer.