Posted on 10/07/2006 in Pharmaceutical Company Product News Roche has announced it has filed Avastin for marketing authorisation in the EU for its use as a first-line treatment for advanced breast cancer.
Avastin has already been approved for colorectal and lung cancers and Roche's latest submission to the European Medicines Agency is based on "impressive" phase III trial data.
A recent trial involved 722 women who were treated with paclitaxel, a chemotherapy drug, with or without Avastin. The study found that the patients who received Avastin had an average disease progression-free survival time of over a year, compared with the paclitaxel-only patients, who showed an average progression-free survival time of approximately six months - an effective doubling of progression-free survival.
Women with HER-2 positive breast cancer were not treated with Avastin, unless they had already tried Herceptin or were unable to receive it.
Eduard Holdener, head of development at Roche Pharmaceuticals, remarked: "Avastin has shown excellent progression-free survival data in treating the disease. he 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 tumour types," he added.
Avastin is the subject of a clinical trials programme expected to include over 40,000 patients as Roche and Genetech test the drug in advanced and adjuvant settings in a variety of cancer types, including, breast, colorectal, lung, pancreatic, ovarian, renal cell carcinoma and prostate.
Roche describes the drug as the first treatment that inhibits angiogenesis - the growth of blood vessels that supplies cancer cells with oxygen and nutrients necessary for them to divide and spread.
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