The Food and Drug Administration has expanded the indications for denosumab (Xgeva), previously indicated for the prevention of skeletal-related events in patients with bone metastases from solid tumors, to include patients with multiple myeloma, according to a press release from Amgen, the manufacturer of Xgeva.
The expanded approval is based on results from the 482 study , a phase 3 clinical trial (NCT01345019) including 1,718 patients with multiple myeloma who received either denosumab or zoledronic acid. Median progression-free survival time was 46.1 months for patients who received denosumab, and 35.4 months for patients who received zoledronic acid. In addition, denosumab was noninferior to zoledronic at delaying the time to first skeletal-related event and in overall survival time.
“Up to 40% of [multiple myeloma] patients remain untreated for the prevention of bone complications, and the percentage is highest among patients with renal impairment at the time of diagnosis. Denosumab, which is not cleared through the kidneys, offers multiple myeloma patients bone protection with a convenient subcutaneous administration, providing patients with a novel treatment option,” Dr. Noopur Raje , director of the Center for Multiple Myeloma, Massachusetts General Hospital Cancer Center, Boston, said in the press release.
Adverse events in multiple myeloma patients were broadly similar to the known safety profile of denosumab. The most common adverse events were diarrhea, nausea, anemia, back pain, thrombocytopenia, peripheral edema, hypocalcemia, upper respiratory tract infection, rash, and headache. The most common adverse event resulting in discontinuation of treatment was osteonecrosis of the jaw.
Find the full press release on the Amgen website .
