Zometa News and Research

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Zometa is a drug used to treat patients with hypercalcemia (high blood levels of calcium) caused by cancer. It is also used together with other drugs to treat multiple myeloma and to prevent bone fractures and reduce bone pain in people who have cancer that has spread to the bone. It is a type of bisphosphonate. Also called zoledronate and zoledronic acid.

Six-year data of reinforces efficacy and safety of Reclast injection in postmenopausal women with osteoporosis

Novartis announced today that new six-year data reinforce the long-term efficacy and safety profile of once-yearly Reclast (zoledronic acid) injection in postmenopausal women with osteoporosis. The study of more than 1,200 women was presented this weekend at the annual meeting of the American Society for Bone and Mineral Research (ASBMR) in Toronto, ON, Canada.

18 Oct 2010

$FDA warns of risk of atypical thigh bone fracture in patients taking bisphosphonates$

FDA warns of risk of atypical thigh bone fracture in patients taking bisphosphonates

The U.S. Food and Drug Administration today warned patients and health care providers about the possible risk of atypical thigh bone (femoral) fracture in patients who take bisphosphonates, a class of drugs used to prevent and treat osteoporosis. A labeling change and Medication Guide will reflect this risk. Bisphosphonates inhibit the loss of bone mass in people with osteoporosis.

14 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

$Bisphosphonates drug may lead to atypical femur fractures in osteoporosis patients: Report$

Bisphosphonates drug may lead to atypical femur fractures in osteoporosis patients: Report

A widely prescribed class of drugs is highly effective in reducing common bone fractures in people with osteoporosis, but an expert panel announced today that these same drugs - when used long term - may be related to unusual but serious fractures of the thigh bone.

14 Sep 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

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

Bone-strengthening drug zoledronic acid can help fight breast cancer DTCs: Study

The bone-strengthening drug zoledronic acid (Zometa) can help fight metastatic breast cancer when given before surgery, suggests research at Washington University School of Medicine in St. Louis.

3 Jun 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

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

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

New data demonstrating the strength of Novartis' hematology portfolio to be presented

Novartis announced today that new data, including a late-breaking presentation on Tasigna® (nilotinib) 200 mg capsules in a form of chronic myeloid leukemia, demonstrate the strength of the company's hematology portfolio in advancing the care of patients.

2 Dec 2009

Cancer pain drug market to be $3.7 billion in 2018

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that, driven by the continued dominance of opioids that include immediate-release morphine and novel fast acting opioid reformulations, the cancer pain drug market will increase from $2.3 billion in 2008 to $3.7 billion in 2018 in the United States, France, Germany, Italy, Spain, the United Kingdom and Japan.

17 Nov 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

FDA approves Reclast (zoledronic acid) for osteoporosis in postmenopausal women

Reclast (zoledronic acid) Injection has been approved by the US Food and Drug Administration (FDA) as the first and only therapy to prevent postmenopausal osteoporosis for two years with a single dose. Reclast is already approved as a once-yearly infusion for the treatment of postmenopausal osteoporosis.

1 Jun 2009

Zometa (zoledronic acid) shown to enhance chemotherapy in reducing breast tumor size

New data released demonstrates that the addition of Zometa (zoledronic acid) injection to standard chemotherapy before breast cancer surgery reduces the size of breast tumors more effectively than chemotherapy alone in women with early-stage disease.

14 Dec 2008

Effectiveness and risks of six bisphosphonates for osteoporosis

Many medications reduce the risk of bone fractures in people with osteoporosis, but the most commonly used drugs - bisphosphonates - have not been proven more effective than alternatives, according to a new report funded by the Agency for Healthcare Research and Quality (AHRQ), part of the U.S. Department of Health and Human Services.

18 Dec 2007

Loyola to study for first time IV medication for osteopenia and inflammatory bowel diseases

Researchers at the Osteoporosis and Metabolic Bone Disease Center and the Division of Gastroenterology at Loyola University Health System are studying a once-yearly, 15-minute infusion of an intravenous (IV) medication in patients with osteopenia (low bone mass) and inflammatory bowel diseases (IBD) that, if proven effective, may be considered the standard of treatment.

10 Jan 2006