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Xgeva Approved to Avoid Fractures in Those with MM
Amgen news release; 2018 Jan 5
The FDA has approved Xgeva (denosumab) to prevent fractures in patients with multiple myeloma.
Indications: Xgeva is a RANK ligand inhibitor indicated for prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors. |
Dosage and administration: Administer 120 mg every 4 weeks as a subcutaneous injection in the upper arm, upper thigh, or abdomen.
Efficacy and safety: Approval is based on results of a phase 3, randomized, double-blind, multicenter trial demonstrating Xgeva’s non-inferiority to zoledronic acid in delaying the time to first on-study skeletal-related event in patients with multiple myeloma.
Side effects/risks: The most common adverse reactions are diarrhea, nausea, anemia, back pain, thrombocytopenia, peripheral edema, hypocalcemia, upper respiratory tract infection, rash, and headache.
FDA approves Xgeva (denosumab) for the prevention of skeletal-related events in patients with multiple myeloma. [news release]. Thousand Oaks, CA: Amgen. January 5, 2018. https://www.prnewswire.com/news-releases/fda-approves-xgeva-denosumab-for-the-prevention-of-skeletal-related-events-in-patients-with-multiple-myeloma-300578047.html. Accessed January 14, 2018.
Xgeva [package insert]. Thousand Oaks, CA: Amgen, 2018. http://pi.amgen.com/~/media/amgen/repositorysites/pi-amgen-com/xgeva/xgeva_pi.pdf. Accessed January 14, 2018.