Amgen To Discuss Application For New Use Of XGEVA® (denosumab) At FDA Oncologic Drugs Advisory Committee Meeting

THOUSAND OAKS, Calif., Feb. 8, 2012 /PRNewswire/ -- Amgen (NASDAQ: AMGN) will discuss the data from 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 (spread of cancer to the bone) at today's meeting of the U.S. Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC).

Amgen will discuss results of the pivotal Phase 3 '147 trial, which forms the basis for the proposed new indication. If approved in this expanded indication, XGEVA would become the first therapy licensed to prevent or delay the spread of cancer to bone in men with CRPC. XGEVA is currently approved to prevent skeletal-related events (SREs) in men with advanced prostate cancer that has already spread to the bone.

"The development of bone metastasis is an irreversible, life-changing event for men living with castration-resistant prostate cancer and is associated with significant and progressive morbidity," said Sean Harper, M.D., senior vice president of Global Development and chief medical officer at Amgen. "XGEVA is the first agent to prolong bone metastasis-free survival and addresses this important unmet medical need."

Bone metastases weaken the skeleton and can result in incapacitating complications known as SREs, which include fracture, spinal cord compression, radiation and surgery to bone.  An estimated 54,000 patients in the U.S. have CRPC with a high risk of developing bone metastases.

'147 Study Design & Results

Study '147 was a randomized, placebo-controlled, multicenter Phase 3 study comparing the treatment effect of XGEVA to placebo in prolonging bone metastasis-free survival, a measure of the time that patients live without progressing to bone metastases.  The study enrolled 1,432 men with CRPC who had no bone metastases at baseline, but were at increased risk based on prostate specific antigen (PSA) criteria. The '147 study enrolled patients with a PSA greater than or equal to 8 ng/mL or PSA doubling time of 10 or less months.