The filing is based on impressive phase III trial data, which show that the addition of Avastin to standard chemotherapy as a primary treatment for advanced breast cancer doubled the time women lived without their disease advancing, compared to chemotherapy alone.
After colorectal and lung cancer, breast cancer is the third type of cancer in which the anti-angiogenic agent Avastin has demonstrated significant survival benefit. Roche plans to file Avastin in Europe later this year in advanced non-small cell lung cancer, the most common form of lung cancer, and to broaden the current label in metastatic colorectal cancer. The drug has already been filed in the US for the treatment of advanced breast cancer.
“The filing is an important milestone, demonstrating that anti-angiogenic therapy is changing the way that cancer is treated. It is a further step forward for Avastin to become part of the treatment armamentarium for a whole range of tumor types,” said Eduard Holdener, head of pharmaceuticals development at Roche.