Amgen Korea said it received approval from the Ministry of Food and Drug Safety for the prefilled syringe formulation of Xgeva (ingredient: denosumab), a treatment for reducing the possibilities of skeletal complications in cancer patients with bone metastases.
The new formulation aims to reduce the risk of skeletal-related events in cancer patients with bone metastases and treat giant cell tumors of bone.
The company expects that the approval of the prefilled syringe will enhance convenience for both patients and healthcare providers. The new formulation minimizes the preparation steps required for the existing vial form, thereby improving ease of use.
Skeletal-related events are a collection of complications that arise from bone metastases in solid tumors and bone infiltration in multiple myeloma, and these complications include pathological fractures, bone surgeries, spinal cord compression, and radiation therapy to bones.
Patients who have experienced skeletal-related events are at risk of recurrence, even with minor impacts, making prevention crucial.
Clinical trials have demonstrated Xgeva's efficacy in various cancer patients with bone metastases, such as those with breast and prostate cancers.
A pooled analysis of three major clinical studies involving patients with solid tumors revealed that the time to first skeletal-related event was 27.7 months for the Xgeva group, 8.2 months longer than the control group.
Additionally, Xgeva reduced the risk of the first skeletal-related event by 17 percent.
The company further stressed that international guidelines, including those from the National Comprehensive Cancer Network (NCCN), recommend initiating treatment with bisphosphonates or Xgeva for patients with bone metastases from breast cancer, prostate cancer, and for those with bone diseases receiving treatment for multiple myeloma.
"Xgeva has significantly reduced the risk of skeletal-related events in patients with multiple myeloma and bone metastases from solid tumors, contributing to maintaining the quality of life for patients worldwide,” Amgen Korea Head of Hemato Oncology Business Unit Kim Mi-seung said. “We are delighted that the launch of the prefilled syringe will offer a more convenient and efficient treatment option for patients and healthcare providers, supporting the journey of cancer treatment."
Xgeva was first approved by the Ministry of Food and Drug Safety in 2014 to reduce the risk of skeletal-related events in patients with bone metastases from solid tumors. In 2015, it received approval for treating giant cell tumors of bone that are unresectable or where surgical resection would result in severe morbidity. The indication was further expanded in 2019 to reduce the risk of skeletal-related events in patients with multiple myeloma.
Xgeva is currently covered under health insurance for patients with breast cancer, prostate cancer with high incidences of bone metastases, and giant cell tumors of bone.