F.D.A. Plans to Revoke Approval for Breast Cancer Drug

The Food and Drug Administration said on Thursday that it would move to revoke approval of the widely used drug Avastin as a treatment for breast cancer, saying the drug was not effective in helping patients.

¶ The decision, which is rare for the F.D.A., has been anticipated since July, when an F.D.A. advisory committee voted 12 to 1 in favor of rescinding approval.

¶The F.D.A. said its recommendation was the start of a process, and that for now, the approval for breast cancer will remain in place and patient access to the drug should not be immediately affected. Genentech, the drug’s manufacturer, will have 15 days to request a hearing. It is expected to do so.

¶ Still, the move could provoke an uproar because various breast cancer patients and some patient advocacy groups have urged the F.D.A. to keep the drug approved and not deny patients a chance at what they say could be a life-saving therapy.

¶The debate even took on political overtones, with some Republican lawmakers saying the move was nothing more than an attempt at cost control, the beginning of rationing under the new health care law.

¶Other breast cancer advocacy groups, however, have agreed with the F.D.A.’s decision, saying patients need drugs that prolong lives or improve the quality of lives, which Avastin had not been shown to do.

¶The decision seems a close one. Indeed, European regulators decided Thursday to retain the approval of Avastin for advanced breast cancer.

¶Avastin, which is sold by Roche and its Genentech subsidiary, will remain on the market as a treatment for other cancers, such as lung and colon cancer. So oncologists will still be able to use Avastin for breast cancer on what is known as an off-label basis.

¶However, insurers will be less likely to pay for such off-label use. And breast cancer treatment will no longer be part of a program in which Genentech caps yearly spending on the drug to $57,000 for patients with annual incomes below $100,000. Without the price cap, Avastin would cost about $88,000 a year for a typical woman with breast cancer.

¶Avastin is the world’s best-selling cancer drug, with annual sales of about $6 billion. Analysts have estimated that revocation of the breast cancer approval could cost Roche $500 million a year or more in lost sales.

¶The rescinding of the approval was done not under the new health care law but under a system set up in the 1990’s to bring drugs for serious diseases to the market quickly, subject to further studies to confirm the drugs are effective.

¶Avastin was given such accelerated approval as a treatment for advanced breast cancer in 2008.

¶But in those further studies, the drug seemed substantially less effective than in the clinical trial that led to the accelerated approval. Avastin did not prolong lives and delayed the worsening of the cancer by only one to three months, while increasing side effects.

¶The F.D.A. advisory committee voted 13-0 in July that the new studies did not confirm the benefit of the drug.

Release link : http://prescriptions.blogs.nytimes.com/2010/12/16/f-d-a-revokes-approval-for-breast-cancer-drug/?src=twt&twt=nytimes

Detecting cancer early

A new testing method is being developed to detect cancer soon after the tumor has formed. It will identify characteristic substances in the blood which accompany a certain type of tumor. The first steps in the development have already been completed.



The earlier the doctor finds the tumor, the better the patient's chances of recovery. A new testing method aims to detect the disease in its initial stages. The technology is based on a microfluidic chip with tiny channels in which a blood sample from the patient circulates. The chip traces marker proteins which are indicative of cancer. The measured concentration of the tumor marker in the blood will help doctors to diagnose the disease at an early stage. Similar testing systems already exist but their measurements are not very precise and they can only detect molecules that are present in the blood in large quantities. What's more, the tests have to be carried out in a laboratory, which is time-consuming and costly. A project funded by the German Ministry of Education and Research and coordinated by the Fraunhofer FIT aims to improve matters. Biofunctionalized nanoparticles developed by research scientists at the Fraunhofer Institute for Silicate Research ISC in Würzburg are the key element in the new sensor. »We have improved the detection limit compared with the present state of the art by a factor of one hundred,« explains Dr. Jörn Probst, Head of the Business Unit Life Science at the ISC. »Whereas previously a hundred molecules were needed in a certain quantity of blood to detect tumor markers, we now need only one. This means that diseases can be diagnosed much earlier than with present methods.«

But how does the biosensor integrated in the chip register the few biomolecules swimming around in the blood that are indicative of a certain disease? »We have placed antibody-occupied nanoparticles on the sensor electrode which fish out the relevant proteins. For this purpose, we repeatedly pump the blood across the electrode surface. As with a river, the flow is fastest in mid-channel and the water runs more slowly near the bank. We have therefore made a sort of fishing rod using nanoparticles which registers the antibodies in the middle of the blood flow where most proteins swim by per unit of time.« If an antibody catches the matching protein, a tumor marker, the electrical charge distribution shifts and this is picked up by the electrode.

The researcher groups are now developing a first demonstrator combining four independent single-molecule-sensitive biosensors. The experts are also working on the simultaneous detection of several tumor markers, which will increase the clarity of tests. The system will be ready to enter the market in a few years' time.

Release link : http://www.fraunhofer.de/en/press/research-news/2010/02/detecting-cancer-early.jsp