Avastin's labeling

February 24, 2008

I believe the NYTimes has said this approval has been granted......

the following artice is NOT from the NYT

February 20, 2008

On Avastin, Why Not Register Results?

http://www.gooznews.com/archives/000973.html

The Food and Drug Administration is considering expanding Avastin's labeling to include breast cancer. The outcome could have major policy implications for future cancer drug approval decisions, since the data submitted by Genentech in support of this anti-angiogenesis drug only shows an increase in time to tumor progression, not an overall survival benefit. The Wall Street Journal's Marilyn Chase this morning provides a good overview of the issues, including their financial implications for insurers, patients and Genentech.

A couple of things stand out. First, the drug's proponents claim that keeping the tumor in check by itself improves quality of life. Yet the side effects of adding Avastin to the traditional chemotherapy regime seem quite nasty. What's the evidence that quality of life was improved by increasing patients' time to tumor progression with this drug?

Moreover, if the data in these short-term trials don't show increased survival, then it is incumbent on the FDA to find out no matter how it decides the immediate issue of expanding the label. Thousands of women are already receiving this drug off-label. That would probably become near universal if it approves the drug for metastatic breast cancer, which kills 45,000 annually.

Traditionally, the FDA has asked companies to conduct post-approval clinical trials to resolve outstanding questions about the benefits and/or risks of a new drug. More often than not, the companies never complete them. In this case, Genentech apparently has one already underway, with data due in a few years.

But the agency could add on another approach. Why not require all physicians who use the drug, whether on or off-label, to keep careful (electronic) records of their patients' performance on the drug, and send that data to the FDA for analysis by the agency's drug evaluation and drug safety units? That data should also be open to outside investigators. (Think of what this would do to promote electronic medical record keeping, but that's another story.)

Observational data is not the same as data from a well-controlled, randomized clinical trial. But it seems to me that researchers would have a valuable new tool for evaluating drugs if the health care system began collecting solid epidemiological data from the real world use of drugs. Such studies would offer patients and their physicians another important source of information when deciding what is the best individual choice when it comes to imperfect drugs like Genentech's Avastin.Posted by gooznews at February 20, 2008 08:33 AM

Comments

Well I see the FDA OKed Avastin for breast cancer. As a supplier of research lab equipment- Genentech is our biggest customer - hooray. But as the husband of a breast cancer 'survivor' I scratch my head and wonder why the FDA did this? I suppose because progress fighting metastatic cancers has been so fruitless, the bar has been lowered again with 'success' now measured in a few months. Whatever happened to the concept of curing a disease? What a cruel hoax this is for these poor unlucky souls- but what a bonanza for Genentech.Posted by: Doc Wrigley at February 22, 2008 04:55 PM

Avastin neither lengthens life nor improves quality of life in metastatic cancer yet is "approved" by the FDA. Approved for what??? Apparently only to enrich the pocketbooks of Genentech who charges $100,000 year for a worthless drug. Unbelievable!!The FDA "bar" is non-existent........as long as a drug can make money for Big Pharma and the Forced Drug Administration.........it will be approved. When will this evil corrupt behavior end? When will Americans wake up and put these white collar criminals in jail?

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