Hospira Inc. (HSP), a provider of injectable drugs and infusion technologies, on Monday revealed positive results from a post-marketing study of its European biosimilar epoetin, Retacrit.
The company noted that the European prospective, observational study met the primary endpoint, as defined by hemoglobin treatment response, in the management of chemotherapy-induced anemia in adult patients with solid tumors, lymphomas and myelomas, regardless of chemotherapy cycle.
The study included 2,310 patients with solid tumors, lymphomas or myelomas. The majority of patients (>80 percent) enrolled in the study achieved a pre-defined hemoglobin response with Retacrit in a real-world clinical setting.
Retacrit was well tolerated in the study with an overall rate of thrombotic events at 3.5 percent, and no epoetin alfa biosimilar-related deaths were reported.
Hospira said that full results of the study, called ORHEO (place of biOsimilaRs in the therapeutic management of anemia secondary to chemotherapy in HEmatology and Oncology), were presented at the 48th Annual Meeting of the American Society of Clinical Oncology.
Retacrit, a recombinant human erythropoietin, or an "EPO biosimilar," was launched in Europe in early 2008. Retacrit is used to treat symptomatic anemia associated with chronic renal failure in adult and pediatric patients and anemia in adult patients receiving chemotherapy for solid tumors, malignant lymphoma or multiple myeloma.
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