Safety and efficacy of switching from branded to generic imatinib in chronic phase chronic myeloid leukemia patients treated in Italy

• Published in: Leukemia research 2018-11, Vol.74, p.75-79
• Main Authors: Bonifacio, Massimiliano, Scaffidi, Luigi, Binotto, Gianni, Miggiano, Maria Cristina, Danini, Marco, Minotto, Claudia, Griguolo, Davide, Marin, Luciana, Frison, Luca, D’Amore, Fabio, Basso, Marco, Sartori, Roberto, Tinelli, Martina, Stulle, Manuela, Fortuna, Stefania, Bonalumi, Angela, Bertoldero, Giovanni, De Biasi, Ercole, Ruggeri, Marco, Semenzato, Gianpietro, Fanin, Renato, Pizzolo, Giovanni, Krampera, Mauro, Tiribelli, Mario
• Format: Article
• Language: English
• Subjects: Adult; Adverse events; Aged; Aged, 80 and over; Branded imatinib; Drugs, Generic - administration & dosage; Drugs, Generic - adverse effects; Female; Follow-Up Studies; Generic imatinib; Humans; Imatinib Mesylate - administration & dosage; Imatinib Mesylate - adverse effects; Italy - epidemiology; Leukemia, Myelogenous, Chronic, BCR-ABL Positive - drug therapy; Leukemia, Myelogenous, Chronic, BCR-ABL Positive - epidemiology; Leukemia, Myelogenous, Chronic, BCR-ABL Positive - pathology; Male; Middle Aged; Molecular response; Savings; Time Factors
• ISSN: 0145-2126; 1873-5835
• DOI: 10.1016/j.leukres.2018.09.018

•In CML patients, switch from branded to generic imatinib appears to be safe.•New or worsening side effects, mostly grade 1–2, were reported by 17% of patients.•Molecular responses remained stable or continued to improve on generic imatinib.•Few patients needed to switch back to branded imatinib or move to other TKIs. The use of generic drugs after patent expiration of their originators is a relative novelty in the treatment of chronic cancer patients in Western countries. In this observational study we analyzed a cohort of 294 Italian chronic phase chronic myeloid leukemia patients treated frontline with branded imatinib (Glivec®) for at least 6 months and then uniformly switched to generic imatinib upon requirement of health authorities in early 2017. Median age at diagnosis was 57 years (range 19–87). Sokal risk was low/intermediate/high in 55%, 32% and 8% of cases, respectively. Median duration of branded imatinib treatment was 7.4 years (range 0.5–16.7). At a median follow-up of 7.5 months after switch to generic imatinib, 17% of patients reported new or worsening side effects, but grade 3–4 non-hematological adverse events were rare. Six patients switched back to branded imatinib, with improvement in the side effect profile, and 4 pts moved to bosutinib or nilotinib for resistance/intolerance. The majority of patients were in major (26%) or deep molecular response (66%) at the time of switch. Molecular responses remained stable, improved or worsened in 61%, 25% and 14% of patients, respectively. We conclude that switch to generic imatinib for patients who have been receiving branded imatinib appears to be effective and safe. Molecular responses may continue to improve over time. Some patients experienced new or worsened side effects but less than 5% of the whole cohort needed to switch back to branded imatinib or move to other treatments. Savings were around 3 million Euros.