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Amgen Announces Results From Phase 3 PAVES Study Evaluating Neulasta® (pegfilgrastim) In Patients With Colorectal Cancer


PAVES is a Phase 3, randomized, double-blind, placebo-controlled trial evaluating Neulasta in 845 patients receiving FOLFOX or FOLFIRI and bevacizumab for the first-line treatment of locally-advanced or metastatic colorectal cancer. The trial was multicenter and multinational. All patients received treatment with either FOLFOX or FOLFIRI plus bevacizumab and were randomized to one of two treatment arms that also received either placebo or 6 mg of Neulasta at least 24 hours after each cycle of chemotherapy. The primary endpoint was the incidence of grade 3 or 4 febrile neutropenia during the first four cycles. The study was not designed to define the febrile neutropenia rate of FOLFOX or FOLFIRI plus bevacizumab. Other endpoints include overall response rate, progression-free survival, overall survival, time to progression and adverse events.

About Febrile Neutropenia

One of the most common side effects of myelosuppressive chemotherapy is a low white blood cell count. 2 An abnormally low level of neutrophils, an important infection-fighting white blood cell, is called neutropenia. 2 The fewer neutrophils a patient has – and the longer the neutrophil count remains low – the greater the risk of developing a potentially serious infection. 2, 3

Febrile neutropenia is neutropenia complicated by a fever. 1 Fever is frequently a sign of infection and, in patients receiving myelosuppressive chemotherapy, it can sometimes be the only sign. 2 Febrile neutropenia is a medical emergency and is associated with several potential downstream consequences. 2, 4

About Neulasta

Neulasta was approved by the U.S. Food and Drug Administration (FDA) in 2002 to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia. 5 Neulasta is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.

Important Safety Information

Do not administer Neulasta to patients with a history of serious allergic reactions to pegfilgrastim or Filgrastim.

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