Denosumab News and Research

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Denosumab is a fully human monoclonal antibody that targets RANK Ligand and is being investigated for its potential to prevent and treat a broad range of bone disease conditions including osteoporosis, bone metastases and their consequences, cancer treatment-induced bone loss due to hormone ablative therapy, multiple myeloma and bone erosions in rheumatoid arthritis. Denosumab is the first late-stage investigational therapy that specifically inhibits RANK Ligand, an essential mediator of the cells that break down bone.

Phase 3 trial demonstrates superiority of Amgen's denosumab over Zometa in preventing SREs

Amgen today announced detailed results from a Phase 3, head-to-head trial which compared the efficacy and safety of denosumab versus Zometa® (zoledronic acid) in 1,901 patients with hormone-refractory prostate cancer and bone metastases. The study met its primary and secondary endpoints and demonstrated denosumab's superiority over Zometa in delaying or preventing skeletal related events (SREs).

7 Jun 2010

Positive results from new analyses of denosumab Phase 3 trials

Amgen today announced positive results from several new analyses of two Phase 3 trials studying denosumab compared with Zometa® (zoledronic acid), the current standard of care, for the treatment of bone metastases in patients with advanced breast cancer ("136 study") and solid tumors or multiple myeloma ("244 study"). Results from these trials reinforce denosumab's consistent ability to delay the complications of bone metastases in patients with advanced cancer. These results are being presented during the 2010 American Society of Clinical Oncology Annual Meeting in Chicago.

5 Jun 2010

Amgen's Prolia receives FDA approval for treatment of postmenopausal women with osteoporosis

Amgen Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved Prolia™ (denosumab) for the treatment of postmenopausal women with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy. Prolia, the first and only FDA-approved RANK Ligand inhibitor, is an every six month 60 mg subcutaneous injection administered by a health care professional.

2 Jun 2010

Amgen announces European approval of Prolia

Amgen Inc. today announced that the European Commission (EC) has granted marketing authorization for Prolia® (denosumab) for the treatment of osteoporosis in postmenopausal women at increased risk of fractures, and for the treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures.

28 May 2010

Halozyme Therapeutics announces delivery of notice of breach to Baxter Healthcare

Halozyme Therapeutics, Inc. today announced the delivery of a notice of breach to Baxter Healthcare Corporation due to Baxter's failure to provide HYLENEX (hyaluronidase human injection) in accordance with the terms of the parties' existing development and supply contracts.

17 May 2010

No increase in risk of glioma or meningioma with use of mobile phones: INTERPHONE project

The International Journal of Epidemiology today published a combined data analysis from a multi national population-based case-control study of glioma and meningioma, the most common types of brain tumour. This is the first in a series of combined data analyses of head and neck tumours published as part of the internationally coordinated INTERPHONE project.

17 May 2010

Amgen submits BLA for denosumab subcutaneous RANK Ligand inhibitor

Amgen Inc. today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for denosumab, a subcutaneous RANK Ligand inhibitor. The BLA submission summarizes clinical experience from nearly 6,900 patients across 18 clinical studies, including approximately 5,700 patients with advanced cancer in the three, pivotal, Phase 3, head-to-head trials versus Zometa® (zoledronic acid).

15 May 2010

U.S. healthcare practitioners can resume use of Rotarix, says FDA

GlaxoSmithKline announced that the Food and Drug Administration has determined that U.S. healthcare practitioners can resume the use of Rotarix (Rotavirus Vaccine, Live, Oral), effective immediately. This action supersedes the FDA's recommendation from March 22, 2010 and reflects the agency's assessment that the presence of porcine circovirus type 1 in the vaccine poses no safety risk.

15 May 2010

FDA assigns Cadence Pharmaceuticals' OFIRMEV NDA new PDUFA action date

Cadence Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has classified the OFIRMEV™ (acetaminophen) injection New Drug Application (NDA) resubmission as a complete Class 2 response to the FDA's February 10, 2010 action letter and assigned a new Prescription Drug User Fee Act (PDUFA) action date of November 4, 2010.

15 May 2010

RANKL inhibition may prove effective in treatment of human malignancy, suggests study

Amgen today announced results of a preclinical study demonstrating a positive response to administration of RANK-Fc against mammary tumor formation in mouse models. OPG-Fc and RANK-Fc bind to and block the action of RANKL. These molecules have a comparable mechanism of action to denosumab. The study was presented today in a late-breaking abstract at the American Association for Cancer Research (AACR) 101st Annual Meeting 2010 in Washington, D.C.

20 Apr 2010

Amgen's Prolia Complete Response submission: FDA classifies and sets PDUFA date

Amgen Inc. today announced that the U.S. Food and Drug Administration (FDA) has evaluated the content of the Company's Complete Response submission for Prolia™ (denosumab) in the treatment of postmenopausal osteoporosis and classified it as a Class 2 resubmission. With the Class 2 designation, the FDA set a corresponding Prescription Drug User Fee Act (PDUFA) action date of July 25, 2010.

20 Feb 2010

Denosumab exhibits superiority over Zometa in treatment of prostate cancer men with bone metastases

Amgen today announced that a pivotal, Phase 3, head-to-head trial evaluating denosumab versus Zometa® (zoledronic acid) in the treatment of bone metastases in 1,901 men with advanced prostate cancer met its primary and secondary endpoints.

9 Feb 2010

European CHMP announces positive opinion for Amgen's Prolia marketing authorization

Amgen Inc. today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has announced a positive opinion for the marketing authorization of Prolia((TM)) (denosumab) for the treatment of osteoporosis in postmenopausal women at increased risk of fractures, and for the treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures.

18 Dec 2009

New data suggests bisphosphonate drug may play a role in reducing recurrent breast cancer

Bisphosphonates are routinely given to women with postmenopausal breast cancer, but new data suggests that these agents may play a role in reducing recurrent breast cancer as well.

11 Dec 2009

Amgen receives Complete Response Letter for the Biologic License Applications for Prolia from FDA

Amgen Inc. today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter for the Biologic License Applications (BLA) for Prolia(TM) (denosumab) in the treatment and prevention of postmenopausal osteoporosis.

19 Oct 2009

Amgen announces results of Phase 3 head-to-head trial evaluating denosumab versus Zometa

Amgen (Nasdaq: AMGN) today announced detailed results from a Phase 3, head-to-head trial evaluating denosumab versus Zometa(R) (zoledronic acid) in the treatment of bone metastases in 2,046 patients with advanced breast cancer that met its primary and secondary endpoints and demonstrated superior efficacy compared to Zometa.

22 Sep 2009

Amgen announces results of Phase 3 trial in the treatment of bone metastases

Amgen (Nasdaq: AMGN) today announced detailed results from a Phase 3 trial evaluating denosumab administered subcutaneously versus Zometa(R) (zoledronic acid) administered as an intravenous infusion in the treatment of bone metastases in 1,776 advanced cancer patients with solid tumors (not including breast and prostate cancer) or multiple myeloma. These results were presented today at the 2009 ECCO 15 - ESMO 34 European Multidisciplinary Congress in Berlin, Germany (Abstract Number: 20LBA).

21 Sep 2009

Amgen to present its four Phase 3 clinical trial results

Amgen today announced it will present detailed data from four Phase 3 studies as well as other data at the ECCO 15 - ESMO 34 European Multidisciplinary Congress, September 20 - 24, 2009 in Berlin, Germany.

16 Sep 2009

Results of PCF funded study could impact the standard of care for prostate cancer patients

Twice-yearly intravenous infusion with denosumab, a new targeted therapy to stop bone loss, increased bone density and prevented spinal fractures in men receiving androgen-deprivation therapy for prostate cancer. The report from an international research study, the first to document reduced fracture risk in men receiving the hormone-blocking treatment, was published today in the print edition of the New England Journal of Medicine (NEJM). Both fundamental research on rank ligand (RANKL) in prostate cancer bone metastasis and other molecular factors involved in the denosumab study were supported at Massachusetts General Hospital with funding from the Prostate Cancer Foundation (PCF).

21 Aug 2009

$Denosumab reduces fractures in postmenopausal women with osteoporosis$

Denosumab reduces fractures in postmenopausal women with osteoporosis

Fractures are a major cause of disability and health care costs among postmenopausal women. Now a study in the New England Journal of Medicine highlights an alternative therapy that prevents fractures in postmenopausal women with osteoporosis.

18 Aug 2009

Denosumab News and Research

Phase 3 trial demonstrates superiority of Amgen's denosumab over Zometa in preventing SREs

Positive results from new analyses of denosumab Phase 3 trials

Amgen's Prolia receives FDA approval for treatment of postmenopausal women with osteoporosis

Amgen announces European approval of Prolia

Halozyme Therapeutics announces delivery of notice of breach to Baxter Healthcare

No increase in risk of glioma or meningioma with use of mobile phones: INTERPHONE project

Amgen submits BLA for denosumab subcutaneous RANK Ligand inhibitor

U.S. healthcare practitioners can resume use of Rotarix, says FDA

FDA assigns Cadence Pharmaceuticals' OFIRMEV NDA new PDUFA action date

RANKL inhibition may prove effective in treatment of human malignancy, suggests study

Amgen's Prolia Complete Response submission: FDA classifies and sets PDUFA date

Denosumab exhibits superiority over Zometa in treatment of prostate cancer men with bone metastases

European CHMP announces positive opinion for Amgen's Prolia marketing authorization

New data suggests bisphosphonate drug may play a role in reducing recurrent breast cancer

Amgen receives Complete Response Letter for the Biologic License Applications for Prolia from FDA

Amgen announces results of Phase 3 head-to-head trial evaluating denosumab versus Zometa

Amgen announces results of Phase 3 trial in the treatment of bone metastases

Amgen to present its four Phase 3 clinical trial results

Results of PCF funded study could impact the standard of care for prostate cancer patients

Denosumab reduces fractures in postmenopausal women with osteoporosis

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