Avastin filed for advanced breast cancer
pharmafile | June 5, 2006 | News story | Sales and Marketing |
Roche and Genentech have filed Avastin in the US for first-line treatment of women with metastatic breast cancer.
The drug has been submitted to the FDA for use in combination with standard chemotherapy for advanced cases of the disease. A decision from the FDA is expected in November 2006.
Avastin (bevacizumab) has been a huge success for the companies, since its launch in 2004, as a treatment for colorectal cancer. The drug earned $1.4 billion (1.66 million Swiss francs) in 2005, and the new indication is expected to help continue its strong growth.
The submission is based on results from a pivotal phase III trial, involving 722 women with previously untreated metastatic breast cancer, which showed that patients receiving Avastin plus Taxol (paclitaxel) had a median progression-free survival (PFS) of more than a year, while patients receiving Taxol alone had a median PFS of around six months.
Eduard Holdener, head of Roche pharmaceuticals development, said: "The addition of Avastin to chemotherapy as a primary treatment for metastatic breast cancer doubled the time women lived without their disease advancing, compared to patients who received chemotherapy alone."
Avastin is the first and, so far, the only anti-angiogenic agent to have demonstrated improved overall and/or progression-free survival in colorectal cancer, non-small cell lung cancer and breast cancer. It is a recombinant humanised antibody to Vascular Endothelial Growth Factor (VEGF), designed to bind to and inhibit VEGF, a protein that plays a critical role in tumour growth.
The FDA first approved Avastin in February 2004 for use in combination with intravenous 5-Fluorourcil-based chemotherapy as a treatment for patients with first-line or previously untreated – metastatic cancer of the colon or rectum.
