FDA Accepts sBLA to Expand Denosumab to Patients With Multiple Myeloma

June 20, 2017
The Center for Biosimilars Staff

Amgen announced Monday that the FDA has accepted its supplemental Biologics License Application for denosumab.

Amgen announced Monday that the FDA has accepted its supplemental Biologics License Application (sBLA) for denosumab (XGEVA). The application seeks to expand the monoclonal antibody’s currently approved indication for the prevention of fractures and other skeletal-related events in patients with bone metastases from solid tumors to include patients with multiple myeloma. The FDA set a Prescription Drug User Fee Act action date of February 3, 2018.

Amgen’s sBLA, submitted in April, is based on the data gathered in a phase 3, randomized, double-blind, multicenter study that met its primary endpoint of demonstrating non-inferiority of denosumab to zoledronic acid in delaying the time to first on-study skeletal-related event in patients with multiple myeloma. The study did not meet its secondary endpoints of demonstrating superiority of denosumab in time to first on-study skeletal-related event and delaying time to first-and-subsequent skeletal-related event.

“Multiple myeloma patients with fractures and other bone complications have a very poor prognosis,” says Sean E. Harper, MD, executive vice president of research and development at Amgen. “Bisphosphonates are the only approved class of agents for the prevention of skeletal-related events in this patient population,” he went on, citing kidney toxicity and acute phase reaction as potential adverse events related to treatment with bisphosphonates. “We look forward to potentially making XGEVA available as a novel option for patients with multiple myeloma,” Harper said.

Multiple myeloma is the second most common hematologic cancer, developing in plasma cells located in the bone marrow microenvironment. This cancer is typically characterized by osteolytic bone lesions and renal impairment. While over 90% of patients with multiple myeloma develop osteolytic lesions during the course of the disease, bisphosphonates are cleared by the kidneys and are associated with renal toxicity. Approximately 60% of patients with multiple myeloma have or will develop renal impairment over the course of the disease.

As denosumab is not cleared by the kidneys, it may provide an opportunity to prevent bone complications—responsible for significant morbidity in patients with multiple myeloma—without increased renal complications.

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