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Denosumab News

FDA Approves Xgeva (denosumab) for the Prevention of Skeletal-Related Events in Patients with Multiple Myeloma

Posted 10 Jan 2018 by Drugs.com

THOUSAND OAKS, Calif., Jan. 5, 2018 /PRNewswire/ – Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for Xgeva (denosumab) to expand the currently approved indication for the prevention of skeletal-related events in patients with bone metastases from solid tumors to include patients with ...

Breast Cancer Drugs Battle Disease's Return

Posted 9 Dec 2015 by Drugs.com

WEDNESDAY, Dec. 9, 2015 – A pair of drugs already on the market appear to reduce the recurrence of breast cancer in women who've already undergone treatment, two new clinical trials show. The chemotherapy drug capecitabine (Afinitor) seems to reduce by nearly a third the risk of breast cancer recurrence if women receive the drug following surgery to remove their cancer, researchers were to ...

Strong Bones After 50? Women May Not Need Next Test Until 65

Posted 9 Jun 2015 by Drugs.com

TUESDAY, June 9, 2015 – A postmenopausal woman who is 50 and still shows "normal" readings on her bone density test may not need her next such test for 10 or even 15 years, a new study finds. However, researchers led by Dr. Margaret Gourlay of the University of North Carolina at Chapel Hill stressed that younger women who do show signs of bone loss are at high risk for a major fracture, and do ...

FDA Approves Xgeva (denosumab) for Hypercalcemia of Malignancy Refractory to Bisphosphonate Therapy

Posted 8 Dec 2014 by Drugs.com

THOUSAND OAKS, Calif., Dec. 8, 2014 /PRNewswire/ – Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved a new indication for Xgeva (denosumab) for the treatment of hypercalcemia of malignancy (HCM) refractory to bisphosphonate therapy. Xgeva was approved and granted Orphan Drug Designation by the FDA, which is reserved for drugs that are intended for ...

Osteoporosis Drugs Work, But Review Finds No Clear Winner

Posted 8 Sep 2014 by Drugs.com

MONDAY, Sept. 8, 2014 – Many osteoporosis drugs cut women's risk of suffering a bone fracture, though it's not clear whether any one medication works better than others, a new research review finds. Reporting Sept. 8 in Annals of Internal Medicine, researchers said that for women with the bone-thinning disease osteoporosis, various drugs cut the risk of a spine fracture by 40 to 60 percent, ...

FDA Approves Xgeva to Treat Giant Cell Tumor of the Bone

Posted 13 Jun 2013 by Drugs.com

June 13, 2013 – The U.S. Food and Drug Administration today expanded the approved use of Xgeva (denosumab) to treat adults and some adolescents with giant cell tumor of the bone (GCTB), a rare and usually non-cancerous tumor. GCTB generally occurs in adults between the ages of 20 and 40 years. In most cases, GCTB does not spread to other parts of the body but destroys normal bone as it grows, ...

Combo Drug Therapy May Work Best to Strengthen Bones: Study

Posted 14 May 2013 by Drugs.com

TUESDAY, May 14 – A new combination drug therapy for osteoporosis appears to increase bone density more effectively than any treatment now on the market, according to the results of a small clinical trial. Researchers found that postmenopausal women experienced significant amounts of bone growth by taking a bone-building drug called teriparatide with denosumab, a targeted therapy drug used to ...

Newer Bone Drug Better for Advanced Breast Cancer Patients: Study

Posted 14 Aug 2012 by Drugs.com

TUESDAY, Aug. 14 – The relatively new drug denosumab (Xgeva) reduces bone complications of advanced breast cancer more effectively than another osteoporosis drug, zoledronic acid (Zometa), according to new research. Zoledronic acid belongs to a class of drugs known as bisphosphonates, which help delay bone complications such as fractures, spinal cord compression and bone pain. But zoledronic ...

FDA Approves New Indications for Prolia (denosumab) for the Treatment of Bone Loss in Patients With Prostate or Breast Cancer Undergoing Hormone Ablation Therapy

Posted 19 Sep 2011 by Drugs.com

THOUSAND OAKS, Calif., September 19, 2011, 2011 /PRNewswire/ – Amgen today announced that the U.S. Food and Drug Administration (FDA) approved two new indications for Prolia (denosumab) as a treatment to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer and as a treatment to increase bone mass in men at high risk for fracture ...

Newer Drug May Help Prevent Fracture in Men With Prostate Cancer

Posted 25 Feb 2011 by Drugs.com

WEDNESDAY, Feb. 23 – A new drug called denosumab (Xgeva) performed somewhat better than the current standard treatment of zoledronic acid (Zometa) for preventing fractures and other bone problems in men with hormone-resistant prostate cancer, a new study suggests. In many patients, prostate cancer becomes resistant to initial hormone treatment within the first few years of diagnosis. As a ...

FDA Approves Amgen's Xgeva (denosumab) for the Prevention of Skeletal-Related Events in Patients with Bone Metastases from Solid Tumors

Posted 22 Nov 2010 by Drugs.com

THOUSAND OAKS, Calif., Nov. 18, 2010 /PRNewswire-FirstCall/ – Amgen Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved Xgeva (denosumab), the first and only RANK Ligand inhibitor for the prevention of skeletal-related events (SREs) in patients with bone metastases from solid tumors. Xgeva was approved following a 6 month priority review by the FDA, a designation ...

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Further Information

Related Condition Support Groups

Osteoporosis, Osteolytic Bone Lesions of Multiple Myeloma, Osteolytic Bone Metastases of Solid Tumors, Giant Cell Tumor of Bone, Hypercalcemia of Malignancy

Related Drug Support Groups

Prolia, Xgeva

Denosumab Patient Information at Drugs.com