Friday, January 28, 2011

FDA to remove Avastin from arsenal for metastatic breast cancer

Patients who have tumors in lung, brain, kidneys and colon cancer can still get treatments Avastin, but the Food and Drug Administration decided that they will withdraw their approval of the drug for use in metastatic breast cancer: oncologists would still be able to prescribe Avastin to treat metastatic breast cancer, but because the FDA can change its status, health insurance does not cover the cost. Patients would give the possibility to pay $ 8000 a month out of pocket for Avastin-a real strain on any budget-but particularly hard on those who have already spent some previous drugs, surgeries and treatments to try to extend their lives for some of these patients with breast cancer, Avastin was the last chance. drug maker-Genentech-FDA decision appeal denying practically treating certain patients of metastatic breast cancer, while the action is pending, and whether a hearing takes place, the State of Avastin remains unchanged. which means that patients who are currently ongoing Avastin should stay tuned and keep track of updates on this issue.

The Food and Drug Administration Avastin were rushed through the approval process two years ago, such as drugs, it seemed that the best new targeted therapy, when used with Taxol (paclitaxel). In Europe, the combination of Avastin and Taxol is used for the treatment of first-line metastatic breast cancer. European Medicines Agency (EMA) stated that "the benefits of this combination outweigh its risks, and that this combination remains a valuable treatment option for patients with metastatic breast cancer."But the FDA U.S. granted initial approval on condition that they say it was not satisfied. The FDA requested that Avastin be put through more clinical studies to see if it would live until follow-up studies were initial results.XML facts, but the FDA says that Avastin benefits somewhat limited shall not exceed its risks and side effects. basis for subsequent studies, Avastin did not inhibit tumor growth by enough to make it useful for patients to tolerate the side effects, without benefit of increased life expectancy. In English, the FDA says that Avastin ? doesn't slow down and make cancer patients live longer without also doing them harm by serious side effects-and talking about patients who have already survived a battery of previous surgeries, chemotherapies and other treatments.

Not all cases of metastatic breast cancer are the same, so that every patient can answer a different treatment. While there are genetic tests that can help predict which tumors will respond to specific drugs, such evidence does not yet cover all types of cancer. head-on some patients believe that Avastin is in possession of their cancer at Bay, giving them more time with their families also some doctors, such as Eric p. Winer, Director of Breast Oncology Center at the Dana Farber Cancer Institute, they say, "this is not a drug useless by any means. There is almost certainly a group of women who get a great benefit. "Fran Visco, National Breast Cancer Coalition disagrees, saying:" the FDA should never endorse Avastin for breast cancer to begin with. we see no evidence of benefit, but we see evidence of evil. "Visco is alluding to the possible effects of Avastin, which may include internal bleeding, perforation of the colon, blood clots and heart failure.

But some suggest that the fight on Avastin is about money. Genentech pays $ 5.8 billion each year for the drug, 855 million, of which comes from use in treatment of breast cancer may not sell if Genentech's blockbuster drug for patients with breast cancer, which is a strong share of income has been pulled out. no wonder they call on the FDA decision! It is not only about altruistic motives, even if maker of Avastin patient assistance-that they cap to $ 57,000 per year for low-income women., which is approximately 7 treatments for patients, for patients with metastatic breast cancer year. more, you may need to be properly treated with Avastin.

Others argue that the real controversy is actually who gets to decide what medicines you may be treated with? does the FDA-a government agency that has the task of protecting patients and adjusting costs-get to decide? do drug companies that spend on research, development and marketing of their products to offer their medications to someone who might be able to afford them? or your oncologist becomes the final arbitor of what can and cannot be dealt with-second or less your insurance-if you-will help cover the cost?

The Komen Foundation has made a statement on the issue, saying that they hope to any patients who actually are benefiting from Avastin will continue to be covered by their insurance company for its use. this critical question back-that will benefit from Avastin ?, and how we expect those patients are? "We urge Genentech/Roche to continue research into a biomarker for Avastin determine which women can benefit from the drug. We are in favour of the drug development process and I hope that manufacturers will continue to develop drugs for the treatment of metastatic breast cancer. We succeed only in the search for new therapies for cancer, bringing new drugs to the clinic, "said Elizabeth Thompson, President of Komen for the cure.

What's your take on the controversy Avastin? Leave a comment right here.

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