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Amgen to Present Pivotal Data From Four Phase 3 Studies at the ECCO 15 - ESMO 34 Congress
Date:9/16/2009

nd deep development program demonstrates Amgen's commitment to researching and delivering pioneering medicines to patients with unmet medical needs. Amgen is studying denosumab in numerous tumor types across the spectrum of cancer induced bone disease. Over 11,000 patients have been enrolled in the denosumab oncology clinical trials testing the drug for bone loss and destruction associated with cancer treatment-induced bone loss in breast and prostate cancers, for the prevention of skeletal related events due to the spread of cancer to the bone in multiple myeloma and multiple solid tumors, and for its potential to delay bone metastases in prostate cancer.

In two phase 3 skeletal related events studies reported to date, the incidence of adverse events and serious adverse events was consistent with what has previously been reported for denosumab and Zometa. Osteonecrosis of the jaw (ONJ) was seen infrequently in both treatment groups.

About Vectibix

Vectibix is the first fully human anti-EGFR approved by the U.S. Food and Drug Administration (FDA) for the treatment of mCRC. Vectibix was approved in the United States in September 2006 as a monotherapy for the treatment of patients with EGFR expressing mCRC after disease progression on or following fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens.

In December 2007, the European Commission granted a conditional marketing authorization for Vectibix as monotherapy for the treatment of patients with EGFR-expressing mCRC with wild-type KRAS genes after failure of standard chemotherapy regimens. Vectibix has been launched in over 20 countries, including Switzerland, Australia and Canada. Applications in the rest of the world are pending.

The effectiveness of Vectibix as a single agent for the treatment of EGFR-expressing, metastatic colorectal carcinoma is based on progression-free survival. Currently no
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SOURCE Amgen
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