Amgen’s Xgeva gets US FDA approval to treat hypercalcemia of malignancy refractory to bisphosphonate therapy

Amgen  today announced that the U.S. Food and Drug Administration (FDA) has approved a new indication for XGEVA^® (denosumab) for the treatment of hypercalcemia of malignancy (HCM) refractory to bisphosphonate therapy. XGEVA was approved and granted Orphan Drug Designation by the FDA, which is reserved for drugs that are intended for the treatment of rare diseases affecting fewer than 200,000 people in the U.S.

CM is a serious complication in patients with advanced cancer, including those with hematologic malignancies, and indicates poor prognosis. The condition results from cancer-driven increases in bone resorption, and if untreated, can lead to renal failure, progressive mental impairment, coma and death.

“Our continued study of XGEVA reinforces Amgen’s ongoing commitment to address the unmet needs of cancer patients,” said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. “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.”

XGEVA binds to RANK Ligand (RANKL), a protein essential for the formation, function and survival of osteoclasts, the cells responsible for bone resorption, thereby modulating calcium release from bone. XGEVA prevents RANKL from activating its receptor, RANK, on the surface of osteoclasts, thereby decreasing bone destruction and calcium release.

About Hypercalcemia of Malignancy

Hypercalcemia of malignancy (HCM) is a serious complication in patients with advanced cancer, including those with hematological malignancies. In 2012, the estimated prevalence of HCM in cancer patients in the U.S. was 2.7 percent. HCM is indicative of poor prognosis and occurs most often in patients with squamous cell cancer (e.g., lung cancer, head and neck cancer), breast cancer, kidney cancer, myeloma and lymphoma. HCM results from cancer-driven increases in bone resorption, and, if untreated, can lead to renal failure, progressive mental impairment, coma and death.

About XGEVA

XGEVA was approved by the FDA for the prevention of skeletal-related events (SREs) in patients with bone metastases from solid tumors in 2010. XGEVA is not indicated for the prevention of SREs in patients with multiple myeloma. In clinical trials, XGEVA demonstrated a clinically meaningful improvement compared to the previous standard of care in preventing SREs. In 2013, XGEVA was approved by the FDA as the first-and-only treatment for adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity.

Ref: 1. Press Release, Amgen, FDA Approves Amgen’s XGEVA® (Denosumab) For The Treatment Of Hypercalcemia Of Malignancy Refractory To Bisphosphonate Therapy 2. XGEVA® (denosumab) prescribing information. Amgen.