Genentech/Roche: another boost for blockbuster Avastin

Genentech submitted the supplemental Biologics License Applications (sBLAs) to the FDA after Avastin (bevacizumab) met its primary endpoint of progression-free survival (PFS) in two separate studies. One application is based on the Phase III AVADO trial in which 736 patients were randomized to receive Avastin or placebo with Taxotere (docetaxel; Sanofi-Aventis), followed by Avastin or placebo until the first event of disease progression or death. Results reported in June 2009 indicated that there was an increase of 49% in PFS among patients receiving Avastin plus Taxotere.

The other application is based on the Phase III RIBBON-1 trial, which evaluated Avastin in combination with Xeloda (capecitabine; Roche), or taxane- or anthracycline-based chemotherapy. The two groups demonstrated improvements in PFS of 45% and 55%, respectively, with the addition of Avastin.

Avastin is an IgG1 monoclonal antibody specifically directed to the vascular endothelial growth factor (VEGF). The VEGF protein is an essential component of the angiogenesis pathway critical for blood vessel formation facilitating tumor growth, invasion and metastasis. Avastin is already approved for the treatment of metastatic HER-2-negative breast cancer in combination with paclitaxel. Indeed, it is a multi-blockbuster drug for Genentech and Roche, with sales of $4.8 billion in 2008.

Breast cancer is the most common cancer in women worldwide, with incidence in the seven major markets forecast to be over 455,000 in 2009. HER-2-positive patients account for 20-25% of the total population and have a poorer prognosis owing to more aggressive tumors, greater lymph node involvement, and a higher rate of recurrence and mortality than those with HER-2-negative tumors.

The FDA had previously granted accelerated approval to Avastin in combination with paclitaxel in this indication, based on a 5.9 month PFS extension shown in the Phase III E2100 trial. Under the FDA's accelerated approval program, drugs can be made available on the market on the basis of preliminary evidence of patient benefit. While Avastin has not been shown to improve overall survival, it has demonstrated an improvement in PFS and there were no unexpected side effects. As such, these latest applications for Avastin stand an excellent chance of gaining FDA approval, and may serve to boost the drug's sales and reaffirm its status as a blockbuster for Roche and Genentech.

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