Cure Today

Xgeva Generates Survival Benefit in Postmenopausal Women With Breast Cancer

"We now finally have evidence that bone-targeted treatment is not only successful in treating bony metastases and preventing treatment-induced bone loss," said Michael Gnant. A follow-up analysis of ...
FiercePharma

Amgen's Xgeva campaign features real cancer patients talking about their lives after diagnosis

A breast cancer diagnosis is devastating. To hear that it has metastasized takes that devastation to another level. Amgen’s “Moments that Matter” campaign for bone metastases drug, Xgeva (denosumab), ...
Reuters

FDA rejects Amgen's application for Xgeva

April 26 (Reuters) - U.S. health regulators rejected the application by Amgen Inc, the world's biggest biotechnology company, to expand the use of the drug Xgeva to delay the spread of tumors to the ...
FiercePharma

XGEVA(TM) (Denosumab) Significantly Improved Bone Metastasis-Free Survival in Men With Prostate Cancer

Amgen (Nasdaq: AMGN) today announced top-line results from a Phase 3 trial evaluating XGEVA(TM) (denosumab) versus placebo in 1,432 men with castrate-resistant prostate cancer. The trial, known as the ...
MM&M

Expanded use of Xgeva a longshot, analysts say

Amgen wants to extend use of bone cancer drug Xgeva (denosumab) into the prevention setting, but analysts, not to mention the FDA’s own advisors, are not optimistic about its chances of securing the ...
CBS News

FDA To Decide By April 26 On New Xgeva Application

Amgen today announced the FDA plans to decide by April 26 on its application to expand the use of its bone treatment drug Xgeva to prevent or delay the spread of advanced prostate cancer. The drug is ...
FierceBiotech

Study Meets Primary Endpoint by Significantly Improving Bone Metastasis-Free Survival for More Than Four Months

THOUSAND OAKS, Calif., May 17, 2011 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced primary results of a pivotal Phase 3 trial ('147) demonstrating that XGEVA™ (denosumab) significantly increased ...
FierceBiotech

The Lancet Publishes Results Demonstrating XGEVA® Significantly Prolonged Bone Metastasis-free Survival in Men With Prostate Can

THOUSAND OAKS, Calif., Nov. 15, 2011 /PRNewswire/ -- Amgen (NASDAQ: AMGN) announced today the publication of results from a Phase 3 trial (the '147 study) that evaluated XGEVA® (denosumab) for use in ...
The Motley Fool

Xgeva and Prolia: Setting the Pace for Amgen, Inc.

Amgen's bone-bulking drugs Xgeva and Prolia are winning market share from Novartis' (NVS) Zometa. Expanding across indications Xgeva and Prolia are different doses of the drug denosumab. They work by ...
Business Insider

FDA Accepts Amgen's Supplemental Biologics License Application To Expand Indication For XGEVA® (denosumab) To Include Multiple Myeloma Patients

XGEVA is the first fully human monoclonal antibody that binds to and neutralizes RANK ligand (RANKL) – a protein essential for the formation, function and survival of osteoclasts, which break down ...
Yahoo Finance

Alvotech Announces Approval of AVT03, a Biosimilar to Prolia® and Xgeva® (denosumab) in the European Economic Area

REYKJAVIK, ICELAND (November 25, 2025) — Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today ...