Yesterday the FDA released a briefing on Genentech’s application to have their cancer drug Avastin be marketed and sold as a viable treatment for breast cancer. The tone of the document does not suggest that Avastin will get the approval it desires. Studies have shown that the drug is effective in slowing the progression of the disease; however, Avastin was not shown to increase the overall survival of patients. In addition, almost 2 percent of those who received chemotherapy in conjunction with Avastin died due to drug related complications.
Genentech claims that the study does show evidence that the Avastin increased overall survival, but the results did not meet the scientific test of significance. They argue that it has been very common for drugs to be approved on the basis of progression free survival. The thinking here is that if a drug slows the progression of the disease it is bound to offer benefits to some patients.
On Wednesday a panel of outside experts will delve deeper into the issue. The panel will have to address whether this drug showing progression free survival, but minimal, if any, increased overall survival coupled with increased toxicity and death if enough to warrant approval for treatment of breast cancer.
For more information on this subject, please refer to the section on Drugs, Medical Devices and Implants.
The Legal Examiner and our Affiliate Network strive to be the place you look to for news, context, and more, wherever your life intersects with the law.