Retrospective post-marketing study on the use of bio-similar pegasparagase among acute lymphoblastic leukemia patients in India

Abstract

Background: Acute lymphoblastic leukemia (ALL) is a cancer of lymphoid progenitor cells with highest incidence among children aged 2–3 years. Pegaspargase, the PEGylated form of L-asparaginase (PEG-ASP) is a component of multidrug regimens used in the management of ALL. Data on experience of PEG-ASP in Indian population is limited. Hence this retrospective post marketing study was carried out. Methods: A total of 77 patients with ALL, who received PEG ASP were included in the study. Out of all the analyzed patients, 57 patients were from a single centre. Results: Anaphylactic and allergic reactions were not reported in any patient. Pancreatitis and venous thrombosis were reported in 4 patients each (5.2%). Subgroup analysis of one centre with data of 57 patients showed similar results as overall data. Conclusions: Bio-similar PEG-ASP in combination with chemotherapy is safe and well tolerated in Indian patients with ALL. No new safety signal was generated in this analysis. Adverse events reported were similar to those seen with innovator in the global published data. Keywords: Acute lymphoblastic leukemia (ALL), Pegaspargase (PEG-ASP), Hypersensitivity, Safety