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.

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

Amgen reports 8% increase in second quarter total product sales to $3,893 million

Amgen reported total revenue increased 4 percent during the second quarter of 2011 to $3,959 million versus $3,804 million in the second quarter of 2010. Total product sales increased 8 percent in the second quarter of 2011 to $3,893 million versus $3,613 million in the second quarter of 2010. The increase in total revenue in the second quarter of 2011 included a decline in other revenue due to certain milestone payments earned in the second quarter of 2010.

29 Jul 2011

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.