1566P - Epoetin zeta for treatment of chemotherapy-induced and cancer-related anaemia: four-year post-marketing surveillance
|Date||01 October 2012|
|Event||ESMO Congress 2012|
|Session||Poster presentation III|
|Topics|| Supportive Care
H.S. Phillips, A. Buckley
Epoetin zeta is a biosimilar erythropoiesis-stimulating agent (ESA) indicated for the treatment of anaemia in adult patients receiving chemotherapy for solid tumours, malignant lymphoma or multiple myeloma, and at risk of transfusion. Approval of biosimilar ESAs in the European Union (EU) requires extensive scientific evaluation and stringent regulatory procedures, ranging from preclinical and clinical studies to tightly controlled manufacturing processes. Post-marketing pharmacovigilance is an integral part of regulatory requirements. This post-marketing surveillance study was undertaken as part of the periodic safety update reports (PSURs) submitted to regulatory authorities.
Aim: To assess the continuing safety of epoetin zeta in treating chemotherapy-induced anaemia.Methods
These post-marketing surveillance data were obtained between 18 December 2007 and 31 December 2011. Adult cancer patients with symptomatic anaemia received subcutaneous epoetin zeta as per the EU summary of product characteristics; 150 IU/kg three times/week, or 450 IU/kg weekly, for 4 weeks. Depending on patient response, subsequent dosage varied between 150 and 300 IU/kg three times/week. A 3-month dosing period was used as average exposure time and total cumulative post-marketing exposure estimate was based on sales of finished product.Results
Patients received approximately 135,000 IU during the initial course of treatment and 405,000 IU during maintenance therapy. The average total dose per patient was 540,000 IU. Over the surveillance period an estimated 17,248,030,000 IU or 31,941 patient-courses were used according to the epoetin zeta oncology indication. The total cumulative post-marketing exposure estimate (combined oncology and nephrology data, post-marketing and clinical exposure data) was approximately 25,770,847,000 IU or 86,159 patient-courses. No reports of neutralising antibodies or cases of pure red cell aplasia have been received to date.Conclusion
The estimated total epoetin zeta patient exposure now exceeds 86,000 patient-courses, of which nearly 32,000 patient-courses have been in the oncology indications. In these patients, no new safety issues have been identified which impact on the established safety profile of the product.Disclosure
H.S. Phillips: Employee of Hospira Ltd.
A. Buckley: Employee of Hospira Ltd.