THOUSAND OAKS, Calif., July 15, 2011 /PRNewswire/ — Amgen
(NASDAQ: AMGN) today announced that the European Commission (EC)
has granted marketing authorization for XGEVA® (denosumab) for
the prevention of skeletal-related events (SREs) (pathological
fracture, radiation to bone, spinal cord compression or surgery to
bone) in adults with bone metastases from solid tumors. This
approval of XGEVA applies to all 27 European Union (EU) member
states. The EC also granted XGEVA an additional year of data and
market exclusivity in the EU since the indication was considered
new for denosumab and based on the significant clinical benefit of
XGEVA in comparison with existing therapies.
Bone metastases, the spread of cancer to the bones, are a common
and serious concern for patients with advanced cancer and present a
burden to the healthcare system. Weakened bones due to metastases
can lead to SREs. The primary goal of treatment for bone metastases
is to prevent the occurrence of these debilitating and costly
SREs.
“Skeletal-related events associated with bone metastases are
truly devastating and painful for patients living with cancer, and
today’s approval of XGEVA marks a real advance,” said Professor
Ingo J. Diel, M.D., Institute for Gynecological Oncology, SPGO,
Mannheim, Germany. “In clinical trials XGEVA demonstrated sustained
protection from SREs and also delayed the progression of pain.
These factors will make a genuine difference in the lives of
patients living with advanced cancer.”
The marketing authorization for XGEVA is based on three pivotal,
Phase 3 head-to-head trials that evaluated the effectiveness of
XGEVA versus zoledronic acid at delaying SREs. The SRE clinical
program for XGEVA spanned more than 50 tumor types in over 5,700
patients. In the SRE trials, XGEVA demonstrated a clinically
meaningful improvement in preventing SREs compared to zoledronic
acid. In these trials, XGEVA was administered every four weeks as a
120 mg subcu
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