Early results of the drug be presented at a cancer Conference in Berlin on Thursday, another piece would to good news this week for men with the disease. On Wednesday, said there was sufficient evidence that the already marketed prostate cancer drug developed by Dendreon Provenge, a Federal Advisory Committee, prolongs life.
This will make it more likely that Medicare is drug, numbers that costs $93.000 a patient and has long been the focus of passionate Debatte.Einige prostate cancer patients, Medicare's review of Provenge saw doctors and investors in Dendreon as the start of a federal crackdown on expensive medications.
The experimental drug XL184, is a biotechnology company in South San Francisco, California, the lead drug candidate of the Exelixis.
Very early tests, 19 of 20 patients showed an improvement in the scans used to determine whether cancer until on the bones spread hat.In could the bone scans sometimes no longer detect cancer and men been able drugs use taxes to be safe bone pain the Einnahme.Um the results very few patients and there was no control group. It is not yet known whether XL184 will take life or how long the improvement of bone scans extended.
"There's really no precedent for other drug that does this," said Dr. Matthew R. Smith, a prostate cancer specialist at Massachusetts General Hospital.
Also, measuring bone of scan actually bone formation, the presence of cancer selbst.So can not it be completely excluded that XL184 somehow bone growth stopped without killing the cancer.However, Dr. Smith said he doubts that was the case because there was evidence that the drug control tumors outside of bone.
Drugs which now have for the treatment of advanced prostate cancer, TAXOTERE, not much affect bone scans, said Dr. Smith.Knochen medications like Zometa Novartis and Denosumab Amgen may protect cancer bone fractures, but have not been shown to fight the cancer.
Another investigator in the study, Dr. David C. Smith from the University of Michigan, he said not believe could, if the bone scan of a patient who had previously widespread cancer in his bones, came back completely clean.
"" I thought you had scanned the wrong person, said Dr. Smith, who is not related to the doctor in Massachusetts.""I have never so something."
Exelixis will add many prostate cancer patients to the midstage clinical trial from which the results were drawn, said Michael M. Morrissey, Managing Director of Unternehmens.Eine late-stage trial could begin as early next year he said.
XL184 is believed to of blood vessels that feed tumors and inhibits a protein called MET, that helps spur to block tumour growth.
Provenge from Dendreon, trains in contrast to the tumor patient's immune system attack.The drug was food and Drug Administration in April after a clinical study showed that those to obtain the drug approved a median survival of about 26 months, four months longer than those in a control group.
Some critics say Medicare were a checking of a drug already approved by the f.d.a wouldn't do for its high cost.
"One must wonder if other is meeting today about something than science, namely the cost" Brad Loncar, an investor in Dendreon, whose Großvater died of prostate cancer, said the Medicare coverage Advisory Committee on Wednesday.
Dr. Louis Jacques, Director of the reporting and analysis group at the Centers for Medicare and Medicaid Services, said costs was not a factor and that the Agency approved products by f.d.a in the past had checked.
Dr. Jacques he said the review ordered wondering why their constituents could not get the drug kontaktiert.Er realized that reimbursement of regional Medicare inconsistent, so he decided a the agency contractors by federal law, uniform national policy should have.
Medicare coverage of Advisory Committee, which met in Baltimore to discuss the cost of Provenge or a cover Empfehlung.Es checked test data from clinical and then rated the strength of the data on a scale of 1 to 5.
10 Cast members, mainly doctors and health policy experts, an average 3.6 to the question how much confidence they had sufficient evidence to conclude that survive Provenge prolongs.
This is between 3 is intermediate trust and 5 which is high Vertrauen.Aber some analysts said that enough for reimbursement sollte.Handel with Dendreon shares are hours during regular market rose 6 percent after hours required.
However, the Panel gave to very low values to prove Medicare could give reasons were the drug prostate cancer patients except the type that would help in the clinical trial, the men with advanced cancer, but none or minimal Symptome.Das for payment refuse if the drug is off - label, as cancer drugs are often used.
Medicare is expected to be a proposed decision for comment by 30 March, with a final decision to put out the end of June.
Provenge has stirred passions because the f.d.a first refused to investors and prostate cancer patients it in 2007 to genehmigen.Einige Dendreon staged protests and advertising campaigns and that sued f.d.a two doctors who had driven investor anger by votes against the drug to an Advisory Committee, meeting for approval attended a major cancer Conference of bodyguards accompanied.
Medicare's review has hundreds of comments, especially to cover gezeichnet.Eine criticism of the drug was submitted from a law firm Willkie Farr and Gallagher, a customer who said the firm wanted to because of the "Public denigration of anyone." Provenge questions remain anonymous,
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