Use of generic imatinib as first-line treatment in patients with chronic myeloid leukemia (CML): the GIMS (Glivec to Imatinib Switch) study
Maria Gemelli, Elena Maria Elli, Chiara Elena, Alessandra Iurlo, Tamara Intermesoli, Margherita Maffioli, Ester Pungolino, Maria Cristina Carraro, Mariella D’Adda, Francesca Lunghi, Michela Anghileri, Nicola Polverelli, Marianna Rossi, Mattia Bacciocchi, Elisa Bono, Cristina Bucelli, Francesco Passamonti, Laura Antolini, Carlo Gambacorti‐Passerini
Abstract
BACKGROUND: Generic formulations of imatinib mesylate have been introduced in Western Europe since 2017 to treat patients with chronic myeloid leukemia (CML). However, results on the safety and efficacy of generic formulations are contrasting. The aim of this study was to investigate the safety and efficacy of generic imatinib in CML patients treated in 12 Italian institutes. METHODS: This is an observational, retro-prospective analysis of patients with CML for whom the treatment was switched from brand to generic imatinib. We analyzed and compared the variation in quantitative PCR values before and after the switch, and the proportion of patients who maintained molecular response after changing from brand to generic imatinib. Adverse events (AEs) were also evaluated. RESULTS: =0.0027). CONCLUSION: Our data indicate that generic imatinib does not have deleterious effects on CML control and present an acceptable safety profile, similar or better than brand imatinib.