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Final Vectibix Positive Pivotal Phase 3 Trial Results In Metastatic,Colorectal Cancer Patients Published

ere dermatologic toxicities were complicated by infection, including sepsis, septic death, and abscesses requiring incisions and drainage. Vectibix may need to be withheld or discontinued for severe dermatologic toxicities.

Severe infusion reactions occurred with Vectibix in approximately 1 percent of patients. Severe infusion reactions were identified by reports of anaphylactic reaction, bronchospasm, fever, chills, and hypotension. Although fatal infusion reactions have not been reported with Vectibix, fatalities have occurred with other monoclonal antibody products. Severe infusion reactions require stopping the infusion and possibly permanently discontinuing Vectibix, depending on the severity and/or persistence of the reaction.

Other important safety information includes:

The most common adverse reactions observed with Vectibix were skin rash with variable presentations, hypomagnesemia, paronychia, fatigue, abdominal pain, nausea and diarrhea. Hypomagnesemia occurred 6 weeks or longer after the initiation of Vectibix. In some patients, hypomagnesemia was associated with hypocalcemia.

Vectibix is indicated for the treatment of EGFr-expressing, metastatic colorectal cancer with disease progression on or following fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens.

The effectiveness of Vectibix for the treatment of EGFr-expressing, metastatic colorectal cancer is based on progression-free survival. Currently no data are available that demonstrate an improvement in disease-related symptoms or increased survival with Vectibix.

AmgenTM Oncology Assistance

Amgen has expanded its patient assistance programs into a comprehensive, multifaceted program with a single gateway - AmgenTM Oncology Assistance. Through this program, patients who are uninsured, underinsured, or unable to afford their insurance co-payments can receive financial support for Amgen's cancer medicines, including Vectibix. T
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