Zoledronic Acid News and Research

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Zoledronic acid 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 Zometa.

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

CytRx to present bafetinib preclinical study results at AACR Annual Meeting

CytRx Corporation, a biopharmaceutical company specializing in oncology, today announced that results from a series of preclinical studies demonstrating that its oncology drug candidate bafetinib inhibits bone destruction in model systems is being presented on April 2, 2011 at the American Academy for Cancer Research 102nd Annual Meeting in Orlando, Florida.

29 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

Zoledronic acid demonstrates anti-angiogenic effects in metastatic lung cancer

A drug that is currently used to help treat bone metastases in patients with lung cancer could also be useful at an earlier stage of treatment, to prevent the cancer from spreading in the first place, Italian researchers have found.

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

Osteoporosis drug reduces bone loss in oral cancer

A drug currently approved for osteoporosis treatment has been shown to reduce bone loss in a study of mice with oral cancer, suggesting it could serve as an important supplemental therapy in patients with head and neck cancers that erode bone.

14 Dec 2010

New osteoporosis drug appears to reduce bone loss in mice with oral cancer

14 Dec 2010

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

Results of Adjuvant Treatment with Zoledronic Acid in Stage II/III Breast Cancer to be presented at symposium

The long-awaited results of the Adjuvant Treatment with Zoledronic Acid in Stage II/III Breast Cancer, the AZURE trial, will be presented at the 33rd Annual CTRC-AACR San Antonio Breast Cancer Symposium, held here Dec. 8-12.

10 Dec 2010

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

Merrion prepares Phase III study for Orazol in breast cancer treatment

After recent consultation with the FDA in November 2010, Merrion is preparing for its Phase III study for Orazol. If successful, the Phase III study will allow a new drug application for Orazol to be made under the FDA's abbreviated approval procedure section 505(b)(2) using a single Phase III study. The study will compare Orazol against placebo as an adjuvant breast cancer treatment with a primary endpoint of Disease Free Survival of patients with breast cancer.

16 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

Novartis announces six-year data of Reclast injection for 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.

19 Oct 2010

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

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