The FDA today approved of a new indication for Amgen's denosumab for the treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.
The FDA today approved of a new indication for Amgen’s denosumab (Xgeva) for the treatment of hypercalcemia of malignancy (HCM) refractory to bisphosphonate therapy.
Xgeva had been approved by the FDA for the prevention of skeletal-related events in patients with bone metastases from solid tumors in 2010, but the drug will now also be available to patients with HCM, a complication that results from cancer-driven increases in bone resorption and can potentially lead to renal failure, progressive mental impairment, coma, and death, according to an Amgen press release.
Around 30 patients with advanced cancer and persistent hypercalcemia from recent bisphosphonate treatment participated in a trial, which studied the number of patients who saw a response measured by albumin-corrected serum calcium <11.5 mg/dL, within 10 days, according to Amgen. More than 63% of patients met the study’s primary endpoint at day 10, Amgen stated.
Amgen noted the most common side effects among patients receiving XGEVA for HCM were nausea, dyspnea, decreased appetite, headache, peripheral edema, vomiting, anemia, constipation, and diarrhea.
"Our continued study of Xgeva reinforces Amgen's ongoing commitment to address the unmet needs of cancer patients," said Sean E. Harper, MD, executive vice president of research and development at Amgen, in a press release. "This latest FDA approval for Xgeva provides an important new therapeutic option for patients with a rare condition that cannot be resolved with bisphosphonate therapy."