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publicado em 07/02/2012 às 09h18:00
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Effectiveness of Xgeva is in doubt for treatments for cancer

FDA says the drug does not contribute to lengthen the life of patients or delay progress of prostate cancer

EFE  
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The Food and Drug Administration of the United States, the Food and Drug Administration (FDA), said on Monday (6) does not yet know whether to approve the use of the drug Xgeva, used to prevent fractures and cancer treatments.

The use of Xgeva is already approved for injection for the prevention of bone fractures in a different formulation in cancer, called Prolia in cases of osteoporosis.

A study by Amgen - U.S. biotech company that produces the treatment - in 1432 patients with prostate cancer and who had stopped responding to hormone treatment, revealed that the drug delayed by more than four months the spread of cancer in the bones compared to patients who received a placebo.

The FDA said in a statement that should determine whether this delay is "an appropriate measure of clinical benefit," since the drug does not contribute to lengthen patients' lives or slow the progress of prostate cancer.

In addition, 5% of patients who used the Xgeva suffered from osteonecrosis, bone death due to lack of blood supply in the jaw.

An advisory committee will rule on Wednesday on whether it considers it appropriate to recommend the use of the drug to prevent cancer extends to the bones. The FDA will decide after the decision of the committee.

Source: EFE
   Palavras-chave:   FDA    Xgeva    Fractures    Bone    Treatments    Cancer    Cancer treatments   
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