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Efficacy, safety, and quality of life of generic and innovator ibrutinib in Indian CLL patients

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Abstract

To report the efficacy, safety, and quality of life (QoL) on generic and innovator ibrutinib in Indian CLL patients. This was a single centre, prospective study of treatment-naive (TN), and relapsed/refractory (R/R) CLL patients receiving ibrutinib in India. The choice of innovator or generic ibrutinib was as per patient discretion. Response and adverse events were recorded as per the 2018 iwCLL guidelines and CTCAEv4.0. QoL was assessed using the EORTC QLQ-C30 and CLL17 questionnaires. A total of 32 CLL patients (TN, n = 7 and R/R, n = 25) received ibrutinib from 2016–2019. The median age was 60 years (37–84). All TN patients attained partial response without any grade 3/4 adverse events (AE). Ibrutinib was less tolerated in the R/R setting, with 52% patients developing grade 3/4 AE and required dose reduction. Eleven patients (44%) died during follow-up. Grade 3–5 infections were seen in 44% of R/R CLL patients. Generic ibrutinib (n = 8) was comparable to innovator ibrutinib (n = 17) in terms of efficacy, safety, and QoL. Ibrutinib is less well tolerated in Indian R/R CLL patients. Infections are a common cause of morbidity and mortality. This study affirms the safety and efficacy of generic ibrutinib.

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Authors and Affiliations

  1. Department of Internal Medicine, Postgraduate Institute of Medical Education and Research, Chandigarh, India

    Charanpreet Singh, Nishant Jindal, Padma Youron, Pankaj Malhotra, Gaurav Prakash, Alka Khadwal, Arihant Jain, Subhash Varma & Deepesh P. Lad

  2. Department of Hematology, Postgraduate Institute of Medical Education and Research, Chandigarh, India

    Sreejesh Sreedharanunni, Man Updesh Singh Sachdeva, Shano Naseem & Neelam Varma

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  1. Charanpreet Singh
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  2. Nishant Jindal
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  3. Padma Youron
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  4. Pankaj Malhotra
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  5. Gaurav Prakash
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  6. Alka Khadwal
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  7. Arihant Jain
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  8. Sreejesh Sreedharanunni
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  9. Man Updesh Singh Sachdeva
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  12. Subhash Varma
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  13. Deepesh P. Lad
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Correspondence to Deepesh P. Lad.

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Singh, C., Jindal, N., Youron, P. et al. Efficacy, safety, and quality of life of generic and innovator ibrutinib in Indian CLL patients. Indian J Hematol Blood Transfus 37, 313–317 (2021). https://doi.org/10.1007/s12288-020-01378-6

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  • DOI: https://doi.org/10.1007/s12288-020-01378-6

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