Amgen (AMGN) to Discuss XGEVA sBLA w/ U.S. FDA ODAC
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.
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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.
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