FDA approved xgeva for hypercalcemia of malignant tumor

Source: on December 8, 2014, DXY Amgen announced that the US FDA increased the indication range of xgeva (dinosemide), which can be used in the treatment of bisphosphonate resistant malignant tumor hypercalcemia "The FDA's latest approval of xgeva provides patients with an important new choice and a solution for patients who cannot use bisphosphonates," said Harper, executive vice president of research and development at Amgen The drug was also approved for orphan drugs, based on data from a clinical trial involving 33 patients with advanced cancer who had recently been treated with bisphosphonates, all of whom had sustained hypercalcemia The primary end point of the trial was to evaluate the patient's response ratio, defined as the albumin corrected serum calcium (CSC) level within 10 days after the first dose of xgeva, which should not exceed 11.5 mg / dl, and the secondary end point included complete remission of the patient, which was defined as the CSC level not exceeding 10.8 mg / dl on the 10th day of response and continuous response The results showed that 63.6% of the patients in the treatment group reached the main end point, and the total corresponding rate was 63.6% Meanwhile, the average response time and the average continuous response time are estimated to be 9 days and 104 days respectively The most common adverse reactions were nausea, dyspnea and loss of appetite Xgeva was initially approved by the FDA in 2010 for the prevention of fracture related events in patients with solid tumor bone metastasis, and the next year in Europe for the same indication Later, xgeva was approved in the United States for the treatment of giant cell tumors of bone in adults and some teenagers The drug is marketed under the trade name Prolia in combination with rank ligands and is suitable for osteoporosis Sales of xgeva and Prolia totaled $573 million in the third quarter, up 31% from the same period last year.