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New Avastin data in advanced breast cancer meets endpoint

Armen Hareyan's picture

Genentech (DNA) has just released new data demonstrating that Avastin (bevacizumab) is effective in metastatic breast cancer:

"A Phase III study (RIBBON 1) of Avastin® (bevacizumab), in combination with taxane, anthracycline-based or capecitabine chemotherapies for first-line treatment of metastatic HER2-negative breast cancer, met its primary endpoint of increasing the time patients lived without their disease advancing, compared to the chemotherapies alone. The primary endpoint of progression-free survival (PFS) was assessed by the treating physicians in the study (investigator-assessed). The safety profile of Avastin was consistent with previous experience and no new safety signals were observed."

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The trial involved 1237 women with advanced breast cancer and the findings of this study, together with the positive PFS results from the E2100 and AVADO Phase III trials support Avastin’s ability to delay cancer progression with commonly used chemotherapies in metastatic HER2-negative breast cancer.

Earlier this year the FDA conditionally approved the drug providing Roche and Genentech file additional data, defying the advice of it's advisory panel, ODAC. However, the RIBBON 1 study should help to convert the accelerated approval granted in February to full approval.

Genentech will likely file the RIBBON 1 and AVADO data to support the full approval in 2009. The RIBBON 1 data may make an appearance at ASCO next June.

Reported by the Pharma Strategy Blog - pharmastrategyblog.com.