Posts tagged ‘avastin’

On Thursday, the American Food and Drug Administration (FDA) recommended that the drug, Avastin, not be utilized by victims of breast cancer as the drug has been found to be ineffectual in diminishing the ferocity of the disease, as per recent investigations on it. Also, the studies have illustrated that Avastin can also engender unpleasant side effects.

The FDA has voiced that the drug’s advantages are overshadowed by its health dangers. The pill had obtained hurried authorization from the FDA in 2008 for usage in treating breast cancer in tandem with chemotherapy. However, four subsequent analyses ascertained that Avastin did not augment the endurance of patients with advanced breast cancer nor did it decelerate the dissemination of the cancer, as per the FDA.

The four independent experimental trials, which examine the usefulness and security of a substance prior to it becoming a permitted drug, did unearth a connection between the drug and intense blood pressure, between the pill and bleeding/ hemorrhage and the growth of holes in the coating that dissociates the right and left nostrils, as well as punctures in the belly and intestines. The FDA has also stated that the drug is allied to cardiological attack and fatal cardiological collapse.

Dr. Janet Woodcock, director of the FDA’s Center For Drug Evaluation and Research, has said that there have been meticulous assessments of the clinical data, after which the FDA is advising that the breast cancer indication for Avastin be extricated anchored in the evidence found.

However, some vociferous American legislators have accused the FDA of possessing bias against the drug on account of its lofty cost. Cost is, by the way, not commanded to be a factor in FDA’s endorsement of any drug. The company, Roche, insists that its Avastin is a credible alternative for breast cancer sufferers.

It must be admitted that the cancellation of the approval of Avastin for curing breast cancer doesn’t signify that the physicians can’t recommend it for that use. It does signify, however, that the insurers may discontinue covering the drug for breast cancer victims. Patient organizations are campaigning to ensure that the insurance businesses continue to shell out for the drug for the patients who are already employing it, notwithstanding the FDA’s negative vote.

Source:

http://news.yahoo.com/s/livescience/20101216/sc_livescience/fdarevokesrecommendationforbreastcancerdrugavastin

http://www.fiercepharma.com/story/fda-ema-rulings-expected-avastin-breast-cancer/2010-12-16

The cancer drug, Avastin, by Roche Holding AG failed yet again to prove its efficacy as a medicine that ensures a disease free existence after surgery in cases of early colon cancer. The drug had failed in a previous study as well.

Although Avastin has been one of the top selling drugs in the US, authorities are still in the process of reviewing its effects on patients suffering from breast cancer. The FDA has been advised by several medical bodies to revoke its approval on the drug.

The FDA will now have to decide on using Avastin for treating breast cancer in combination with different types of chemotherapies. Avastin’s label still indicates that it can be used in instances of metastatic breast cancer and will continue to remain so until the FDA gives its decision by December 17, this year.

The international study AVANT, conducted by Roche, revealed that a year long treatment with Avastin, along with standard chemotherapy does not necessarily reduce the risk of a relapse, particularly in cases of early colon cancers. The drug has failed to be effective in the late stages of colon cancer as well. A statement issued by Basel, Switzerland-based Roche, says that the preliminary data reveals chemotherapy alone to be enough in ensuring a disease free survival. It does not need to be combined with Avastin.

The researchers from the group are now engaged in studying the results from this study as well as an earlier one (C-08) in order to arrive at a conclusion about the steps of an ongoing post surgery treatment by using Avastin as an adjuvant.

Source: http://uk.reuters.com/article/idUKLDE68J0JK20100920

http://uk.reuters.com/article/idUKLDE68J04I20100920?loomia_ow=t0:s0:a49:g43:r1:c0.280000:b37453732:z0

http://www.bloomberg.com/news/2010-09-18/roche-s-avastin-fails-to-help-early-stage-colon-cancer-patients-in-study.html