Cabozantirib has been approved by the U.S. Food and Drug Administration for use against metastatic medullary thyroid cancer. The approval came even though the medication did not show it prolonged survival overall in any clinical trials.
Evidently the regulatory agency was sufficiently satisfied with results from trials that showed a significant progression free survival rate and mild toxicity with a broad kinase inhibitor, that was formerly known by the symbol XL 184.
One of the doctor?s involved in the approval process for the FDA said Cometriq is the second FDA approved drug for medullary thyroid cancer in the last two years and it reflects the commitment by the FDA for the developing and approval of drugs that treat rare diseases.
A study that led to the approval of cabozantirib showed a mean progression free rate of survival of just over 11 months compared to just 4 months for the placebo group. The clinical results also showed that over 27% of patients that had been treated with Cometriq experienced reductions in the size of tumors for close to 15 months, while those patients receiving placebos saw no size reductions in their tumors.
Cabozantirib will contain a warning on the box that fistulas and perforations in the colon had been experienced by some patients. However, the most common side effects included mucositis, diarrhea, anorexia, hand-foot syndrome, fatigue, nauseas, graying hair, worsened or new hypertension, constipation and abdominal pain.
The drug is also being studied for use in ovarian cancer and prostate cancer.
Source: http://www.healthaim.com/drug-for-thyroid-cancer-gets-approval-from-fda/
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