Amgen reports good interim safety and efficacy results from Phase II trial of Xgeva
Biotechnology company Amgen has reported planned interim safety and efficacy results from Phase II trial of a fully human monoclonal antibody, Xgeva (denosumab), in patients with giant cell tumour of bone (GCTB). (Source: Drug Development Technology)
Source: Drug Development Technology - July 16, 2013 Category: Pharmaceuticals Source Type: news
Denosumab Approved by FDA for Giant-Cell Tumor of the Bone
The first treatment for a rare tumor called giant-cell tumor of the bone has been approved by FDA. The approval of denosumab (Xgeva) was based on a priority FDA review. (Source: Cancer Network)
Source: Cancer Network - June 20, 2013 Category: Cancer & Oncology Source Type: news
Xgeva (Denosumab) Approved For Giant Cell Tumor Of The Bone Treatment, FDA
Xgeva (denosumab) has been approved by the U.S. FDA for the treatment of GCTB (giant cell tumor of the bone) in adults and skeletally mature adolescents. GCTB is a rare tumor which is usually non-cancerous. Giant cell tumor of the bone typically affects adults aged between 20 and 40 years. In the majority of cases, GCTB remains localized (does not spread). However, as it grows it destroys normal bone, resulting in severe pain, bone fractures and a limited range of motion. GCTB can become malignant and spread to the lungs, however this is rare... (Source: Health News from Medical News Today)
Source: Health News from Medical News Today - June 14, 2013 Category: Consumer Health News Tags: Bones / Orthopedics Source Type: news
Xgeva Approved for Rare, Non-Malignant Tumor
Title: Xgeva Approved for Rare, Non-Malignant TumorCategory: Health NewsCreated: 6/13/2013 2:35:00 PMLast Editorial Review: 6/14/2013 12:00:00 AM (Source: MedicineNet Medications General)
Source: MedicineNet Medications General - June 14, 2013 Category: Drugs & Pharmacology Source Type: news
FDA approves Xgeva to treat giant cell tumour of the bone
The US Food and Drug Administration yesterday announced that it has expanded the approved use of Amgen's Xgeva to cover the treatment of giant cell tumour of the bone (GCTB), a rare and usually non-cancerous tumour. (Source: Pharmaceutical Technology)
Source: Pharmaceutical Technology - June 13, 2013 Category: Pharmaceuticals Source Type: news
FDA Approves Amgen's XGEVA(R) (denosumab) For The Treatment Of Giant Cell Tumor Of Bone
XGEVA Becomes First FDA-Approved Treatment for This Rare Disease
THOUSAND OAKS, Calif., June 13, 2013 -- (Healthcare Sales & Marketing Network) -- Amgen (AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved a new indicati... Biopharmaceuticals, Oncology, FDAAmgen, XGEVA, denosumab, giant cell tumor of bone (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - June 13, 2013 Category: Pharmaceuticals Source Type: news
FDA Expands Denosumab for Giant Cell Tumor of BoneFDA Expands Denosumab for Giant Cell Tumor of Bone
The drug becomes the first systemic therapy for a rare condition. FDA Approvals (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - June 13, 2013 Category: Consumer Health News Tags: Hematology-Oncology News Alert Source Type: news
Xgeva OK'd for Rare Bone Tumor
(MedPage Today) -- SILVER SPRING, Md. -- The bone-active biologic drug denosumab (Xgeva) may be used to treat giant cell tumor of the bone when surgery is contraindicated, the FDA announced Thursday. (Source: MedPage Today Campaign '08)
Source: MedPage Today Campaign '08 - June 13, 2013 Category: American Health Source Type: news
FDA approves Xgeva to treat giant cell tumor of the bone
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. (Source: Food and Drug Administration)
Source: Food and Drug Administration - June 13, 2013 Category: American Health Source Type: news
Combination Drug Therapy May Be Best Treatment For Osteoporosis
The combination of two different drugs for osteoporosis was found to increase bone mineral density (BMD) more than treatment with either drug alone, according to the results of a small clinical trial published in The Lancet. The combination, which included teriparatide, a bone-building (anabolic) drug, and denosumab, a targeted therapy to stop bone loss, also increased BMD better than previously reported with any available treatment in postmenopausal women with osteoporosis... (Source: Health News from Medical News Today)
Source: Health News from Medical News Today - May 17, 2013 Category: Consumer Health News Tags: Clinical Trials / Drug Trials Source Type: news
Teriparatide-Denosumab Combo Strengthens Postmenopausal BoneTeriparatide-Denosumab Combo Strengthens Postmenopausal Bone
A combination of teriparatide, which builds bone, and denosumab, which reduces bone loss, improved bone density in postmenopausal women compared with either drug alone. Medscape Medical News (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - May 15, 2013 Category: Consumer Health News Tags: Internal Medicine News Source Type: news
Treatment with 2 osteoporosis drugs better at increasing bone density than single-drug therapy (EurekAlert, 14 May 2013)
A study in The Lancet assesses combination therapy combining denosumab and teriparatide vs either therapy alone in a total of 94 women with postmenopausal osteoporosis. Full article (Source: Society for Endocrinology)
Source: Society for Endocrinology - May 15, 2013 Category: Endocrinology Source Type: news
Denosumab Helps Boost BMD After MenopauseDenosumab Helps Boost BMD After Menopause
Postmenopausal women with low bone mineral density (BMD) who previously received bisphosphonates will have greater increases with denosumab (Prolia, Amgen) than with ibandronate. Reuters Health Information (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - May 14, 2013 Category: Consumer Health News Tags: Ob/Gyn & Women ' s Health News Source Type: news
Forteo Plus Prolia Builds Bone (CME/CE)
(MedPage Today) -- Treatment with a combination of teriparatide (Forteo) plus denosumab (Prolia) led to greater increases in bone mineral density in postmenopausal women with osteoporosis than either agent alone, a randomized trial showed. (Source: MedPage Today Endocrinology)
Source: MedPage Today Endocrinology - May 14, 2013 Category: Endocrinology Source Type: news
MHRA Drug Safety Update: Denosumab 60 mg (Prolia) and rare cases of atypical femoral fracture with long-term use
Source: MHRA
Area: Evidence > Medication Safety
The February Drug Safety Update from the MHRA includes information on the development of atypical femoral fractures that have been reported rarely in patients with postmenopausal osteoporosis receiving long-term (?2.5 years) treatment with denosumab 60 mg (Prolia) in a clinical trial.
The following advice has been issued to healthcare professionals:
. During denosumab treatment, patients should be advised to report new or unusual thigh, hip, or groin pain. Patients presenting with such symptoms should be evaluated for an incomplete femoral frac...
Source: NeLM - Patient Safety - February 21, 2013 Category: Drugs & Pharmacology Source Type: news
