Osteonecrosis of the Jaw News and Research

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Bisphosphonate benefit for breast cancer yet to be proven

Older patients with breast cancer may benefit from adjuvant treatment with oral bisphosphonates, but further studies are needed before general application in the breast cancer population, say researchers.

19 Jun 2012

$Women with spine fractures can benefit from alendronate therapy$

Women with spine fractures can benefit from alendronate therapy

Continuing a popular but controversial treatment for osteoporosis could reduce spine fracture risk for a particular group of patients, but others could see little to no change if they discontinue it. Based on available evidence, a UCSF researcher reevaluated his 2006 finding from a randomized 10-year study of alendronate, a type of bisphosphonate - a class of drugs that prevent loss of bone mass.

10 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

Maturitas publishes EMAS' clinical guide on SERMs against postmenopausal osteoporosis

Elsevier, a world-leading provider of scientific, technical and medical information products and services, announced today the publication of an important clinical guide from the European Menopause and Andropause Society (EMAS) in the February issue of Maturitas.

29 Feb 2012

FDA panel votes against Amgen’s Xgeva in prostate cancer

An FDA panel of oncologists has voted against a new use for Amgen's Xgeva in prostate cancer on Wednesday, saying the drug's ability to slow the spread of the disease did not translate into meaningful benefits for patients. Xgeva is already approved to prevent fractures in cancerous bones, and for osteoporosis, in a different formulation called Prolia.

9 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

New discovery paves way for genetic screening test

Researchers at the Columbia University College of Dental Medicine have identified a genetic variation that raises the risk of developing serious necrotic jaw bone lesions in patients who take bisphosphonates, a common class of osteoclastic inhibitors.

27 Jan 2012

Adjuvant zoledronic acid shows promise against ER-positive premenopausal breast cancer

Researchers have proven the continuing effectiveness of treating patients with estrogen receptor-positive premenopausal breast cancer with adjuvant zoledronic acid in addition to adjuvant endocrine treatment including ovarian function suppression.

8 Dec 2011

FDA reviews safety issues of bisphosphonates for osteoporosis

An advisory committee for U.S. Food and Drug Administration meets Friday to review the safety of a popular class of osteoporosis drugs called bisphosphonates amid worry that their long-term use could cause rare fractures of the thighbones and affect the jawbone. The committee will evaluate whether women should temporarily stop using the drugs or use them for only a few years.

6 Sep 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

Celgene announces results of REVLIMID, docetaxel/prednisone phase II combination study on mCRPC

Celgene International Sàrl today announced results from a phase II investigator initiated study of REVLIMID (lenalidomide) in combination with Avastin (bevacizumab), docetaxel and prednisone in patients with metastatic castration-resistant prostate cancer were presented at the 2011 American Society of Clinical Oncology Annual Meeting in Chicago, Ill.

6 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

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

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

Oral bisphosphonates outweigh the risk associated with jaw disease

A commonly prescribed osteoporosis drug is associated with a slightly elevated risk of developing the rare, but serious condition, osteonecrosis of the jaw; nonetheless the risk remains extremely low. These findings are published online in the Journal of Dental Research, the official journal of the International and American Associations for Dental Research.

14 Feb 2011

JDR releases research report on Osteonecrosis of the jaw

Osteonecrosis of the jaw is a debilitating bone condition that affects the jaws and occurs as a result of reduced local blood supply to the bone. The literature in this area has been severely limited since most investigations cannot evaluate sufficient numbers of afflicted individuals to accurately determine the incidence of the disease and associated risk factors.

14 Feb 2011

Zometa improves OS, PFS in newly diagnosed multiple myeloma patients: Phase III study

A newly published study in the Lancet suggested that a first-line treatment regimen including Zometa (zoledronic acid) significantly improved overall survival and progression-free survival in newly diagnosed multiple myeloma patients compared with a regimen that included oral clodronate. The impact on survival was independent of the effect of Zometa on bone complications (also known as skeletal-related events or SREs).

4 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