FDA Approves Amgen's Xgeva For HCM
By Cyndi Root
The Food and Drug Administration (FDA) has approved Amgen’s Xgeva (denosumab) to treat hypercalcemia of malignancy (HCM) refractory to bisphosphonate therapy. Amgen announced the new indication in a press release, stating that Xgeva is an FDA designated Orphan Drug. Sean E. Harper, MD, executive VP of Research and Development at Amgen, said, "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
In HCM, cancer-driven bone resorption increases can lead to renal failure, cognitive deficits, and death. Xgeva modulates calcium release from the bone by binding to RANK Ligand (RANKL), a protein essential in osteoclasts, bone resorption cells. Xgeva (also marketed as Prolia) was approved by the FDA in 2010 to prevent skeletal-related events (SREs) in patients with bone metastases from solid tumors. The federal agency approved the agent due to the clinically meaningful improvements patients experienced when taking Xgeva, compared to the standard of care. The FDA approved the agent in 2013 for patients with giant cell tumor of bone that is unresectable or where surgery is too dangerous.
The FDA expanded the Xgeva indication to include HCM based on a study of patients with persistent hypercalcemia after recent bisphosphonate treatment. The primary endpoint was the proportion of patients with albumin-corrected serum calcium (CSC) response. The study met the endpoint with 63 percent of the 33 patients achieving a response at day 10. The overall complete response rate was 63.6 percent, the median time to response was nine days, and the median duration of response was 104 days.
Amgen Activities
The FDA approved another Amgen agent in December 2014. The immunotherapy Blincyto (blinatumomab) treats a rare blood and bone marrow cancer, Philadelphia chromosome-negative (Ph-) relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). The agent is approved, however, Amgen must continue studies on patient survival rates.
In November 2014, Amgen announced that it was terminating its studies of rilotumumab in advanced gastric cancer. The termination was due to an independent data monitoring committee (DMC) review, which found increased deaths in the rilotumumab group. Amgen stated that while it is terminating company-sponsored studies, other entities such as the National Cancer Institute (NCI) are currently conducting studies of rilotumumab.