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.

$IOF outlines guidelines to help prevent osteoporosis and fractures in cancer patients$

IOF outlines guidelines to help prevent osteoporosis and fractures in cancer patients

Cancer is a health burden of increasing importance which affects close to 13 million people globally. Bone is often affected in these patients, frequently because of bone metastases, or as a result of anti-cancer therapies which can contribute to bone loss and fragility.

4 Nov 2013

Amgen presents data from several romosozumab and Prolia at ASBMR 2013 Annual Meeting

Amgen today announced that it will present data from several romosozumab and Prolia® (denosumab) studies at the American Society for Bone and Mineral Research (ASBMR) 2013 Annual Meeting in Baltimore from Oct. 4-7, 2013.

5 Oct 2013

Xgeva receives FDA approval for treating 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, a rare and usually non-cancerous tumor.

14 Jun 2013

Denosumab associated with improved overall survival in NSCLC patients

It is common for patients initially diagnosed with lung cancer to have the cancer spread to sites like the liver, brain and bone. One of the most frequent sites of metastases is the bone, with an estimated 30 to 40 percent of patients with non-small-cell lung cancer (NSCLC) developing bone loss.

16 Nov 2012

$Denosumab gives FREEDOM to heal fractures$

Denosumab gives FREEDOM to heal fractures

Results from the FREEDOM trial indicate that fracture healing is not impaired in women with osteoporosis who use the antiresorptive therapy denosumab.

2 Nov 2012

Exelixis announces interim data from cabozantinib phase 2 trial on metastatic CRPC

Exelixis, Inc. today announced interim data from 51 patients with metastatic castration-resistant prostate cancer (CRPC) and bone metastases receiving a 40 mg daily dose of cabozantinib in an ongoing non-randomized expansion (NRE) cohort of a phase 2 randomized discontinuation trial.

1 Oct 2012

Denosumab effective in treating giant-cell tumor of the bone

Treatment with denosumab, a drug targeted against a protein that helps promote bone destruction, decreased the number of tumor giant cells in patients with giant-cell tumor of the bone, and increased new bone formation, according to the results of a phase II study published in Clinical Cancer Research, a journal of the American Association for Cancer Research.

24 Sep 2012

Amgen receives FDA approval for Prolia to treat bone loss in men with osteoporosis

Amgen today announced the U.S. Food and Drug Administration (FDA) approved a new indication for Prolia (denosumab) as a treatment to increase bone mass in men with osteoporosis at high risk for fracture.

21 Sep 2012

Positive updated interim data from Exelixis’ cabozantinib phase 2 trial on CRPC

Exelixis, Inc. today reported positive updated interim data from an ongoing phase 2 trial of cabozantinib in men with metastatic castration-resistant prostate cancer (CRPC) and bone metastases.

6 Jun 2012

Study: Breast cancer in young women is enriched with aggressive basal-like tumors

Breast cancer in young women is a biologically unique disease that requires customized management strategies, researchers report at the 4th IMPAKT Breast Cancer Conference, in Brussels, Belgium.

4 May 2012

FDA issues Complete Response Letter to Amgen’s sBLA for XGEVA

Amgen today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter for the supplemental Biologics License Application (sBLA) for XGEVA (denosumab) to treat men with castration-resistant prostate cancer (CRPC) at high risk of developing bone metastases.

27 Apr 2012

Four new drugs can extend survival and prognosis of prostate cancer

After a decade and a half of near stagnation, four new drugs could help make advanced prostate cancer a chronic illness instead of a terminal disease, a leading Colorado prostate cancer expert says.

17 Feb 2012

FDA reviews Amgen’s prostate cancer drug Xgeva

U.S. Food and Drug Administration (FDA) researchers say that an Amgen drug slowed the spread of cancer to the bone in men with hard-to-treat prostate cancer, though the drug did not extend life and carried significant side effects.

7 Feb 2012

FDA invites Amgen for ODAC meeting on XGEVA sBLA to treat castration-resistant prostate cancer

Amgen today announced the U.S. Food and Drug Administration has invited the Company to participate in a meeting of the Oncologic Drugs Advisory Committee (ODAC) on Feb. 8, 2012 to discuss the supplemental Biologics License Application (sBLA) for XGEVA (denosumab) to treat men with castration-resistant prostate cancer (CRPC) at high risk of developing bone metastases.

30 Dec 2011

Amgen's XGEVA delays onset of bone metastases in men with prostate cancer

Amgen announced today the publication of results from a Phase 3 trial (the '147 study) that evaluated XGEVA (denosumab) for use in preventing or delaying the onset of bone metastases in men with nonmetastatic castration-resistant prostate cancer.

16 Nov 2011

Exelixis reports cabozantinib phase 2 trial data on bone metastases

Exelixis, Inc. today reported interim data on pain relief and related reduction in narcotic analgesic use with cabozantinib in castration-resistant prostate cancer (CRPC) patients with bone metastases.

14 Nov 2011

NCKU research team discovers potential target to treat osteoporosis

A National Cheng Kung University (NCKU) research team has discovered that a protein called interleukin (IL)-20 is a key to treating osteoporosis, a disease that lowers a person's bone density.

7 Oct 2011

Data from Amgen's XGEVA and Vectibix studies to be presented at EMCC 2011

Amgen announced today that data from XGEVA (denosumab) and Vectibix (panitumumab) studies will be presented at the 2011 European Multidisciplinary Cancer Congress, Sept. 23 - 27, 2011, in Stockholm, Sweden.

23 Sep 2011

Amgen's Prolia receives FDA approval for new indications to treat cancer patients

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 receiving androgen deprivation therapy for non-metastatic prostate cancer.

19 Sep 2011

Amgen to present data from several Prolia studies at ASBMR 2011 meeting

Amgen today announced that it will present data from several Prolia (denosumab) studies, including eight year efficacy and safety data from a Phase 2 extension study in women with postmenopausal osteoporosis with low bone mineral density (BMD), at the 2011 American Society for Bone and Mineral Research (ASBMR) Annual Meeting in San Diego, Calif. from Sept. 16-20, 2011.

19 Aug 2011