Safety Concerns Prompt FDA to Negatively Review Genentech/Roche's Avastin® For Breast Cancer.

PRLog (Press Release) - Jan 25, 2008 -
Report Buyer, the online destination for business intelligence for major industry sectors, has added a new report which finds that an FDA advisory panel has suggested that Genentech/Roche's Avastin® should not receive FDA approval for metastatic breast cancer.

“Pipeline Insight: Molecular Targeted Cancer Therapies - Can anything else revolutionize the market?” which is available at http://www.reportbuyer.com/go/DAT08284, finds that as the FDA usually follows the panel's recommendation, concerns were raised over the drug's future. It however, states that a number of reasons may still drive US approval of the drug in metastatic breast cancer.

Genentech/Roche's anti-angiogenic, monoclonal antibody Avastin® (Bevacizumab) was given a negative recommendation for metastatic breast cancer over safety concerns and the panel's decision sent Genentech's shares to a two-and-a-half year low. The drug's fate now lies in the hands of the FDA, which will consider the panel's recommendation in deciding whether to grant Avastin approval for metastatic breast cancer.

The report says Avastin was the first anti-angiogenesis inhibitor to enter the oncology market. It finds that Genentech, majority-owned by Roche, holds Avastin's marketing rights in the US, where the drug made sales of $1.7 billion in the first nine months of 2007. Avastin has been approved in the US and EU for the first-line treatment of metastatic colorectal cancer and in the US for the treatment of non-small cell lung cancer. In March 2007, Avastin was approved in the EU for the first-line treatment of metastatic breast cancer in combination with the standard chemotherapy paclitaxel.

Analysts say that in Avastin's pivotal study in metastatic breast cancer, 722 patients received paclitaxel or paclitaxel in combination with Avastin. Avastin was shown to extend progression-free survival by 5.5 months, but not overall survival. However, patients in the Avastin group were found to have a 20% increase in serious side effects including hypertension, blood clots and heart attacks.

Authors of the report find that in the drug's recent review, FDA staff suggested that the improvement in progression-free survival should be weighted against the potentially fatal toxicity. The FDA, which usually follows the advisory panel's advice, will now consider the panel's negative recommendation in deciding whether to approve Avastin for breast cancer.

The study clarifies that Avastin is already used off-label in the US for metastatic breast cancer. However, FDA approval would allow the drug to be promoted for this indication and help in reimbursement for insurers. If approval is granted, Avastin is expected to change the first-line treatment of metastatic breast cancer.

The publication states that despite ODAC's negative recommendation and despite its questionable toxicity profile, the FDA is likely to approve Avastin even though it only achieved an incremental improvement in progression-free survival. Avastin's approval in the EU for breast cancer, its extensive off-label use in breast cancer in the US, and the high patient and physician awareness may all force a positive FDA decision.

“Pipeline Insight: Molecular Targeted Cancer Therapies - Can anything else revolutionize the market?” is available from Report Buyer. For more information go to: http://www.reportbuyer.com/pharma_healthcare/diseases/can...

Report Buyer product ID: DAT08284