Efficacy, safety, and quality of life of generic and innovator ibrutinib in Indian CLL patients
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Efficacy, safety, and quality of life of generic and innovator ibrutinib in Indian CLL patients Charanpreet Singh1 • Nishant Jindal1 • Padma Youron1 • Pankaj Malhotra1 • Gaurav Prakash1 • Alka Khadwal1 • Arihant Jain1 • Sreejesh Sreedharanunni2 Man Updesh Singh Sachdeva2 • Shano Naseem2 • Neelam Varma2 • Subhash Varma1 • Deepesh P. Lad1
•
Received: 22 July 2020 / Accepted: 5 November 2020 Ó Indian Society of Hematology and Blood Transfusion 2020
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. Keywords CLL Generic Innovator Ibrutinib
Electronic supplementary material The online version of this article (https://doi.org/10.1007/s12288-020-01378-6) contains supplementary material, which is available to authorized users. & Deepesh P. Lad [email protected] 1
Department of Internal Medicine, Postgraduate Institute of Medical Education and Research, Chandigarh, India
2
Department of Hematology, Postgraduate Institute of Medical Education and Research, Chandigarh, India
Introduction Ibrutinib is approved for the treatment of all lines of Chronic Lymphocytic Leukemia (CLL) [1]. Long term data from two randomised phase III trials have shown its continued efficacy in treatment-naive (TN) (RESONATE) and relapsed/refractory (R/R) CLL patients (RESONATE-2) [2, 3]. In-fact ibrutinib based regimens have been shown to be superior to chemo-immunotherapy (CIT) in TN-CLL patients [4, 5]. The high cost of ibrutinib has precluded its use in low-middle income countries (LMIC). Innovator ibrutinib (Imbruvica, Janssen Biotech, Inc.Horsham, PA USA) is available in India through a patient assistance program from 2016. Generic ibrutinib (Ibrunat, Natco pharmaceuticals, India) is available in India from 2019. We describe here our experience of innovator and generic ibrutinib at our centre in TN and R/R CLL.
Methods This was a single centre, pr
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