BioCentury
ARTICLE | Clinical News

FDA approves sBLA for Amgen's Xgeva for MM patients

January 12, 2018 4:21 PM UTC

Amgen Inc. (NASDAQ:AMGN) said FDA approved an sBLA for Xgeva denosumab (Prolia, Pralia, Ranmark, AMG 162) to prevent skeletal-related events in adults with multiple myeloma (MM) ahead of its Feb. 3 PDUFA date.

Amgen already markets the drug to prevent skeletal-related events in patients with bone metastases from solid tumors; to treat 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; and to treat hypercalcemia of malignancy refractory to biphosphonate therapy...