Denosumab批准治疗什么病症？

It is a fully human antibody from Amgen targeting NF-κB receptor activator ligand (RANKL). From the initial target discovery to the successful development of a fully human antibody, Didinosumab has a classic research and development history. So what diseases can denosumab treat clinically? Clinical trial results have proven that didenosumab can reduce bone resorption and improve bone quality and bone strength, so it can be used to treat osteoporosis.

In addition, in tumor treatment applications, the expression of RANKL is increased in bone metastasis or multiple myeloma, leading to increased osteoclast activity and osteolysis. Inhibiting RANKL can prevent osteolysis and tumor growth caused by tumor metastasis. Therefore, Denosumab also has application value in tumor treatment. In June 2010, the FDA approved denosumab (trade name: Prolia®) for the treatment of osteoporosis in postmenopausal women, and was later approved for the treatment of osteoporosis in men, bone loss caused by androgen deprivation therapy for prostate cancer, and bone loss caused by aromatase inhibitor therapy for breast cancer.  

In November of the same year, based on the results of three randomized controlled phase III clinical studies, the FDA approved Denosumab (trade name: In addition, Amgen is continuing to expand new indications for Denosumab. For example, in January 2018, the FDA approved Denosumab for the treatment of SREs in patients with multiple myeloma. Denosumab also received orphan drug designation for the treatment of giant cell tumor of bone and malignant hypercalcemia.  

Warnings and Precautions for Denosumab:

(1) Do not use the same active drugs: patients taking denosumab should not use other monoclonal antibody drugs.

(2) Allergic reactions may occur when using denosumab; if allergic reactions occur, the medication should be discontinued permanently.

(3) Hypocalcemia: Denosumab may cause severe symptoms of hypocalcemia, or be fatal. Hypocalcemia should be corrected before medication, and the patient's blood calcium level should be monitored during treatment, especially in the first week of first medication, and calcium and vitamin D should be supplemented appropriately.

(4) Osteonecrosis of the jaw (ONJ): Osteonecrosis of the jaw (ONJ) has been reported. Oral examination should be performed before medication, symptoms should be observed during treatment, and any invasive dental procedures should be avoided.

(5) Atypical femoral fracture: Assess the patient’s thigh or groin pain to diagnose atypical femoral fracture.

(6) Embryo-fetal toxicity: Denosumab harms the fetus. Women of childbearing age should be informed of the dangers of this drug and take effective contraceptive measures.

(7) Hypercalcemia after discontinuation of medication: Monitor patient’s symptoms and treat appropriately.