Roche said this morning it had filed for approval of its cancer drug Avastin as a treatment for non-small cell lung cancer in the European Union, continuing the rapid roll-out of new indication for its ‘pipeline in a product’.
Avastin (bevacizumab) is already approved for colorectal cancer and has also been filed for approval in breast cancer in Europe and the USA, although Roche suffered a disappointment after there were disappointing results for Avastin in pancreatic cancer. The company filed Avastin for the NSCLC indication in the USA in April.
The expansion of its labelling to include breast cancer and NSCLC would give Avastin a green light in the three most common cancers, and add momentum to an already fast-growing product. Sales of the drug soared 119% to 1.4 billion Swiss francs ($1.14bn) in the first six months of 2006.
Roche claims Avastin is the first medicine to have been shown to extend survival in previously untreated patients with NSCLC beyond one year.
The drug has been submitted for use in addition to platinum-based therapy for NSCLC patients who have the non-squamous cell form of the disease. Earlier studies with Avastin in NSCLC had revealed that a few patients developed bleeding in the lungs – known as hemoptysis – which seemed to occur in patients with squamous cell forms of the cancer, so Roche has designed a trial programme that excludes these patients.
The core of the dossier came from a US study (E4599) which found that non-squamous cell NSCLC patients treated with Avastin plus paclitaxel and carboplatin chemotherapy had a 20% reduction in the risk of death compared to patients receiving chemotherapy alone, while the median survival in the Avastin group was 12.3 months, compared to 10.3 months for the chemotherapy arm.
Progression-free survival increased by a third to 6.4 months with Avastin, while the overall response rate was 29%, compared to 13% in the control group. Meanwhile, the risk of hemoptysis was 2.3% in the Avastin plus chemotherapy group.
The filing also included preliminary results from the AVAiL trial, which is looking at the value of adding Avastin to platinum ‘doublet’ (gemcitabine and cisplatin) chemotherapy, although this study is not due to generate results until next year.