Amgen Aranesp, Vectibix Setbacks Illustrate Risks Of Real World Trials
Amgen's failed Anemia of Cancer trial of Aranesp and Panitumumab Advanced Colorectal Cancer Evaluation (PACCE) trial of Vectibix may illustrate the potential pitfalls facing sponsors that conduct "real world" trials of their products
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Amgen is working with Johnson & Johnson to ensure that a consistent message regarding the safety profile of erythropoiesis-stimulating agents is presented to FDA's Oncologic Drugs Advisory Committee
Amgen will continue to evaluate patients in its completed Phase III study of Aranesp in anemia of cancer after determining that use of darbepoetin alfa was associated with higher mortality risk
Amgen's pending oncologic panitumumab will be priced between Genentech's Avastin and Bristol-Myers Squibb/ImClone's Erbitux, Exec VP-Commercial Operations George Morrow said