Avastin Hits the Breast Cancer Indication Wall

A Brief History of Avastin

Avastin (its generic name: bevacizumab) was developed by the biotechnology giant–Genentech (bought by Roche in March 2009), and was first approved by the U.S. FDA in 2004.  Avastin is a biologic antibody targeting “vascular endothelial growth factor” that involves in blood vessel formation.  By disturbing the blood vessel formation (a.k.a. angiogenesis) in tumors, the tumor cells lose nutrition and oxygen supplies and therefore die.  Avastin, in combination with intravenous 5-fluorouracil-based chemotherapy, has been used in treatment of several solid tumors, like metastatic colorectal cancer, metastatic kidney cancer, and non-small cell lung cancer.  In addition, in combination with paclitaxel (another chemotherapy drug), Avastin was used in treatment of metastatic HER2-negative breast cancer patients.  Unfortunately, the new clinical data from US trials showed that Avastin is not effective.  Based on the new scientific data, the FDA recently had decided to recommend removal of breast cancer indication from Avastin label.

Contrary Results of Avastin in Breast Cancer Treatment

Initially, I was grieved by Avastin’s failure of showing benefits in disease-related symptoms or survival to breast cancer patients.  But turn on my glass is half-full thought, at least Avastin is still valid in other treatment indications.  However, Genetech, the company marketing the drug doesn’t think so because the European Medicines Agency gave a green light to Avastin, arguing against FDA’s recommendation of Avastin removal from breast cancer indication.  Genentech will request a hearing with FDA by 18 January 2011.

Some Sticky Issues in FDA’s Decision on Avastin

In 2008, Avastin was granted “accelerated approval” for metastatic breast cancer treatment in combination with paclitaxel (called E2100 study).  Few years later, more science-based evidence from two clinical trial studies (named AVADO and RIBBON1) showed that Avastin did not benefit breast cancer patients.  Some patients claimed Avastin is helpful and are afraid the FDA’s decision will affect Medicare reimbursement because the annual spending of Avastin can reach $88,000, not many patients can afford such expensive treatment if Medicare doesn’t pay for it (or part of it).  You can read more on:

Until next post, keep on reading and writing!!  Happy New Year 🙂

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About fdabiomed
I like to read, organize, and write about biomedical related topics. I am passionate to learn new things, particularly news related to the Food and Drug Administration's decision and announcement.

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