• Expansion of Indication Offers Patients a New Treatment Option
• Approval Based on Safety and Efficacy Data From the Largest Inter­na­tional Multiple Myeloma Clinical Trial Ever Conducted

Thousand Oaks, CA (Press Release) – Amgen (NASDAQ: AMGN) today announced that the U.S. Food and Drug Admin­istra­tion (FDA) has approved the supple­mental Biologics License Application (sBLA) for XGEVA® (denosumab) to expand the cur­rently approved indi­ca­tion for the prevention of skeletal-related events in patients with bone metastases from solid tumors to in­clude patients with multiple myeloma. The approval is based on data from the pivotal Phase 3 '482 study, the largest inter­na­tional multiple myeloma clin­i­cal trial ever conducted, which enrolled 1,718 patients.

"Up to …

• Xgeva is Currently Indicated for the Prevention of Skeletal-Related Events Known as Bone Complications in Patients With Solid Tumors
• Applications Include Data From the Largest Inter­na­tional Trial Conducted in Multiple Myeloma

Thousand Oaks, CA (Press Release) – Amgen (NASDAQ: AMGN) today announced the sub­mission of a supple­mental Biologics License Application (sBLA) to the U.S. Food and Drug Admin­istra­tion (FDA) and an appli­ca­tion for a variation to the market­ing authori­za­tion to the European Medicines Agency (EMA) for XGEVA® (denosumab). The sub­missions to regu­la­tory author­i­ties seek to expand the cur­rently approved XGEVA indi­ca­tion for the prevention of skeletal-related events (SREs) in solid tumors to in­clude patients with multiple myeloma. The appli­ca­tions in­clude new data from the pivotal …

Study met Primary Endpoint of Non-Inferiority Versus Zoledronic Acid in Delaying Bone Complications Known as Skeletal-Related Events

Thousand Oaks, CA (Press Release) – Amgen (NASDAQ: AMGN) today announced that a Phase 3 study eval­u­ating XGEVA® (denosumab) versus zoledronic acid met the pri­mary end­point of non-inferiority (hazard ratio = 0.98, 95 per­cent CI, 0.85 - 1.14) in delaying the time to first on-study skeletal-related event (SRE) in patients with multiple myeloma. The sec­ond­ary end­points of superiority in delaying time to first SRE and delaying time to first-and-subsequent SRE were not met. The hazard ratio of XGEVA versus zoledronic acid for over­all survival was 0.90 (95 per­cent CI, 0.70 - 1.16). …

Additional results from a Phase 3 study show that Xgeva may be more effective than Zometa in treating bone disease in multiple myeloma patients. Specifically, Xgeva was better than Zometa in reducing bone fractures, limiting the need for bone radiation treatment, and preventing the worsening of pain in cancer patients with bone disease.

Despite these findings, physicians are likely to remain cautious about treating myeloma patients with Xgeva, as there are concerns about the drug's safety when used in myeloma patients.

Bone disease is a common complication of multiple myeloma. Bone-destroying cells …

Multiple myeloma is the most frequent cancer to involve the skeleton, with up to 80 percent of patients having bone disease. Although fewer patients appear to have bone involvement more recently, it is still a major source of both complications and death among patients with myeloma.

Bone disease is so severe in myeloma because the normal bone remodeling process is disrupted. In normal individuals, damaged bone is removed by bone-destroying cells, the osteoclasts, and then bone is replaced by bone-forming cells, the osteoblasts. In myeloma, the number and activity of the bone-destroying …

This past Sunday was the third day of the American Society of Clinical Oncology (ASCO) 2011 annual meeting, and it was a particularly busy day for meeting attendees interested in multiple myeloma.

The Beacon published an update yesterday covering two sets of presentations made at Sunday’s oral session about multiple myeloma.  This article covers the other set of presentations, which was about myeloma bone disease, as well as material from an afternoon education session focused on myeloma.

Myeloma Bone Disease

The …

This year’s American Society of Clinical Oncology (ASCO) annual meeting, which began on Friday and goes through Tuesday, is being held in Chicago.

On the first day of the meeting, there was only one talk related to multiple myeloma.  During an afternoon education session, in which current practice and recent research results are reviewed, Dr. Raphael Fonseca from the Mayo Clinic in Scottsdale, Arizona, spoke about high-risk multiple myeloma.

The second day of the meeting included a morning and an afternoon session in which myeloma researchers presented their findings in the form …