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.

EC grants marketing authorization for Amgen's XGEVA to prevent skeletal-related events

Amgen today announced that the European Commission (EC) has granted marketing authorization for XGEVA (denosumab) for the prevention of skeletal-related events (SREs) in adults with bone metastases from solid tumors.

15 Jul 2011

Amgen files sBLA for XGEVA with FDA to treat castrate-resistant prostate cancer

Amgen today announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) to expand the indication for XGEVA (denosumab) to treat men with castrate-resistant prostate cancer to reduce the risk of developing bone metastases.

28 Jun 2011

EMA CHMP recommends positive opinion for marketing authorization of Amgen's XGEVA

Amgen today announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has recommended a positive opinion for the marketing authorization of XGEVA (denosumab) for the prevention of skeletal-related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with bone metastases from solid tumors.

20 May 2011

New denosumab Phase III trial data in high-risk prostate cancer presented at AUA conference

Data on the use of denosumab (Xgeva) to improve bone metastases-free survival in men with high-risk prostate cancer was presented at the American Urological Association conference today for the first time.

18 May 2011

Amgen announces primary results from XGEVA Phase 3 trial in castrate-resistant prostate cancer

Amgen today announced primary results of a pivotal Phase 3 trial demonstrating that XGEVA significantly increased bone metastasis-free survival for more than four months in men with castrate-resistant metastatic prostate cancer that has not yet spread to bone.

18 May 2011

Prolia associated with greater adherence than alendronate in postmenopausal women with osteoporosis

Amgen today announced new data that showed postmenopausal women with osteoporosis had significantly greater adherence, compliance, and persistence during Prolia® (denosumab) treatment than during alendronate treatment, an oral bisphosphonate commonly used to treat osteoporosis.

24 Mar 2011

Updated NCCN Guidelines for Breast Cancer outline expanded treatment options

Women with metastatic breast cancer have expanded treatment options for treating the disease and in the prevention of skeletal-related events as outlined in the recently updated NCCN Guidelines™ for Breast Cancer. Robert W. Carlson, MD, of Stanford Comprehensive Cancer Center and chair of the NCCN Guidelines Panel for Breast Cancer, presented these and other notable updates to the NCCN Guidelines at the NCCN 16th Annual Conference on March 10, 2011.

11 Mar 2011

The Lancet journal publishes XGEVA Phase 3 study results against prostate cancer, bone metastases

Amgen today announced the publication of results from a Phase 3 head-to-head trial that compared XGEVA to Zometa in preventing bone complications called skeletal-related events in 1,901 men with prostate cancer and bone metastases.

25 Feb 2011

Amgen announces publication of XGEVA Phase 3 study results against solid tumors in Journal of Clinical Oncology

Amgen today announced the publication of results from a pivotal Phase 3 study of 1,776 advanced cancer patients with different types of solid tumors or multiple myeloma, which compared XGEVA to Zometa in preventing skeletal-related events.

23 Feb 2011

Quebec provides access to new treatment for women with postmenopausal osteoporosis

Today Quebec is providing access to a therapy in a new class of osteoporosis treatments. With Quebec being the first province to list Prolia on public and private drug plans, Canadians living with osteoporosis in the province of Quebec now have access to increased treatment options.

2 Feb 2011

Denosumab delays skeletal-related side effects in patients with breast cancer and bone metastases

For patients with breast cancer and bone metastases, denosumab delayed skeletal-related side effects five months longer compared to those on zoledronic acid, according to results presented at the 33rd Annual CTRC-AACR San Antonio Breast Cancer Symposium, held Dec. 8-12.

13 Dec 2010

Xgeva receives FDA approval for prevention of SREs in patients with bone metastases

The U.S. Food and Drug Administration approved Xgeva (denosumab) on Thursday to help prevent skeletal-related events (SREs) in patients with cancer that has spread (metastasized) and damaged the bone. Skeletal-related events include bone fractures from cancer and bone pain requiring radiation.

19 Nov 2010

Denosumab superior to Zometa in preventing SREs in breast cancer patients with bone metastases: Study

Amgen today announced the publication of results from a pivotal Phase 3 study of 2,046 patients which compared denosumab with Zometa® (zoledronic acid) in delaying or preventing skeletal-related events (SREs) in breast cancer patients with bone metastases. An SRE consists of any of the following: a pathologic fracture, the need for radiation or surgery to ameliorate bone pathology secondary to tumor growth, or spinal cord compression.

8 Nov 2010

Amgen wins Scrip Best New Drug award for Prolia

Amgen is pleased to announce that it has won the Best New Drug award for Prolia™ (denosumab), a novel treatment approved in the United States (U.S.) for women with postmenopausal osteoporosis at high risk for fracture, at the 2010 Scrip Awards ceremony Nov. 4 in London. Named one of TIME's Top 10 Medical Breakthroughs of 2009, Prolia is the first treatment specifically designed to target osteoclasts, the cells that break down bone.

8 Nov 2010

Amgen reports $3,816 million for 2010 third quarter revenue

Amgen reported revenue unchanged for the third quarter of 2010 at $3,816 million versus $3,812 million for the third quarter of 2009.

26 Oct 2010

Amgen to present oncology portfolio results at ESMO Congress

Amgen today announced that results from several important studies from the Company's ncology portfolio will be presented at the 35th European Society for Medical Oncology (ESMO) Congress, Oct. 8-12, 2010, in Milan, Italy.

6 Oct 2010

HRT therapy can increase breast cancer risk

Breast cancer is one of the most common cancers, affecting up to one in eight women during their lives in Europe, the UK and USA. Large population studies such as the Women's Health Initiative and the Million Women Study have shown that synthetic sex hormones called progestins used in hormone replacement therapy, HRT, and in contraceptives can increase the risk of breast cancers.

30 Sep 2010

Amgen second-quarter total revenue increases 2% to $3,804 million

Amgen reported adjusted earnings per share (EPS) of $1.38 for the second quarter of 2010, an increase of 7 percent compared to $1.29 for the second quarter of 2009. Adjusted net income increased 1 percent to $1,326 million for the second quarter of 2010 compared to $1,311 million for the second quarter of 2009.

30 Jul 2010

Amgen granted FDA priority review designation for denosumab BLA

Amgen today announced that the U.S. Food and Drug Administration (FDA) has granted priority review designation to denosumab, a subcutaneous RANK Ligand inhibitor, for the treatment of bone metastases to reduce skeletal related events (SREs) in patients with cancer.

17 Jul 2010

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