New bone cancer drug approved by the FDA

New bone cancer drug approved by the FDA

A promising new drug to minimize the risk of skeletal-related events among bone cancer patients was approved by the U.S. Food and Drug Administration. Denomusab, also marketed as Xgeva and Prolia for osteoporosis cases, is the first RANKL inhibitor to receive approval for this kind of treatment. The FDA based its favorable decision on the results of three phase III clinical trials.

Denomusab, made by California-based Amgen, is administered to cancer patients whose cancer has spread to the bones through the subcutaneous route of 120 mg per four weeks for the mitigation of skeletal-related events such as fractures. For osteoporosis in postmenopausal women, the drug is given at a dose of 60 mg twice a year. The FDA gave the approval for denomusab’s use for osteoporosis last June.

The subcutaneous route of denosumab makes it possible to be administered to more patients compared to zolendronic acid, which is administered intravenously.

The study found that denomusab was more effective than zoledronic acid or Zometa in preventing skeletal-related events among 5,700 patients with more than 50 types of tumors. It was notably most effective when given to prostate or breast cancer patients with bone metastases.

With regards to side-effects and adverse reactions like excessive calcium levels and jaw osteonocrosis, the rates of denomusab and zoledronic acid were identical. Similar incidence of nausea, fatigue, breathlessness and increased phosphate levels in the blood between the two drugs were also noted. Renal safety of denomusab was also found to be satisfactory. The overall survival rate among bone cancer patients was also similar between the two drugs.

Posted by George Daniels on Saturday November 20 2010, 4:33 AM EST. Ref: Medscape. All trademarks acknowledged. Filed under Featured News, Health. Comments and Trackbacks closed. Follow responses: RSS 2.0