1,098
Views
0
CrossRef citations to date
0
Altmetric
Original Research

A real-world pharmacovigilance study of FDA Adverse Event Reporting System (FAERS) events for Bruton’s tyrosine kinase inhibitors (BTKis) single and its combination therapy

ORCID Icon, , , , , , & ORCID Icon show all
Pages 627-636 | Received 05 Oct 2023, Accepted 03 Jan 2024, Published online: 18 Mar 2024

References

  • Burger JA, Wiestner A. Targeting B cell receptor signalling in cancer: preclinical and clinical advances. Nat Rev Cancer. 2018;18(3):148–167. doi: 10.1038/nrc.2017.121
  • Burger JA, Barr PM, Robak T, et al. Long-term efficacy and safety of first-line ibrutinib treatment for patients with CLL/SLL: 5 years of follow-up from the phase 3 RESONATE-2 study. Leukemia. 2020;34(3):787–798. doi: 10.1038/s41375-019-0602-x
  • Sharman JP, Egyed M, Jurczak W, et al. Acalabrutinib with or without obinutuzumab versus chlorambucil and obinutuzmab for treatment-naive chronic lymphocytic leukaemia (ELEVATE TN): a randomised, controlled, phase 3 trial. Lancet. 2020 Apr 18;395(10232):1278–1291. doi: 10.1016/s0140-6736(20)30262-2
  • Tam CS, Opat S, D’Sa S, et al. A randomized phase 3 trial of zanubrutinib vs ibrutinib in symptomatic Waldenström macroglobulinemia: the ASPEN study. Blood. 2020 Oct 29;136(18):2038–2050. doi: 10.1182/blood.2020006844
  • Swerdlow SH, Campo E, Pileri SA, et al. The 2016 revision of the World Health Organization classification of lymphoid neoplasms. Blood. 2016 May 19;127(20):2375–2390. doi: 10.1182/blood-2016-01-643569
  • Sutanto F, Konstantinidou M, Dömling A. Covalent inhibitors: a rational approach to drug discovery. RSC Med Chem. 2020 Aug 1;11(8):876–884. doi: 10.1039/d0md00154f
  • O’Brien SM, Brown JR, Byrd JC, et al. Monitoring and managing BTK inhibitor treatment-related adverse events in clinical practice. Front Oncol. 2021;11:720704. doi: 10.3389/fonc.2021.720704
  • Lewis KL, Cheah CY. Non-covalent BTK inhibitors—the new BTKids on the block for B-Cell malignancies. J Pers Med. 2021 Aug 3;11(8):764. doi: 10.3390/jpm11080764
  • Hauben M, Bate A. Decision support methods for the detection of adverse events in post-marketing data. Drug Discov Today. 2009;14(7–8):343–357. doi: 10.1016/j.drudis.2008.12.012
  • Shanafelt TD, Wang XV, Hanson CA, et al. Long-term outcomes for ibrutinib-rituximab and chemoimmunotherapy in CLL: updated results of the E1912 trial. Blood. 2022 Jul 14;140(2):112–120. doi: 10.1182/blood.2021014960
  • Byrd JC, Harrington B, O’Brien S, et al. Acalabrutinib (ACP-196) in relapsed chronic lymphocytic leukemia. N Engl J Med. 2016 Jan 28;374(4):323–332. doi: 10.1056/NEJMoa1509981
  • Wen T, Wang J, Shi Y, et al. Inhibitors targeting Bruton’s tyrosine kinase in cancers: drug development advances. Leukemia. 2021 Feb;35(2):312–332. doi: 10.1038/s41375-020-01072-6
  • Jain N, Keating M, Thompson P, et al. Ibrutinib and venetoclax for first-line treatment of CLL. N Engl J Med. 2019 May 30;380(22):2095–2103. doi: 10.1056/NEJMoa1900574
  • Dimopoulos MA, Tedeschi A, Trotman J, et al. Phase 3 trial of ibrutinib plus rituximab in Waldenström’s macroglobulinemia. N Engl J Med. 2018 Jun 21;378(25):2399–2410. doi: 10.1056/NEJMoa1802917
  • Wang M, Ramchandren R, Chen R, et al. Concurrent ibrutinib plus venetoclax in relapsed/refractory mantle cell lymphoma: the safety run-in of the phase 3 SYMPATICO study. J Hematol Oncol. 2021 Oct 30;14(1):179. doi: 10.1186/s13045-021-01188-x
  • Moreno C, Greil R, Demirkan F, et al. Ibrutinib plus obinutuzumab versus chlorambucil plus obinutuzumab in first-line treatment of chronic lymphocytic leukaemia (iLLUMINATE): a multicentre, randomised, open-label, phase 3 trial. Lancet Oncol. 2019 Jan;20(1):43–56.
  • Wu J, Liu C, Tsui ST, et al. Second-generation inhibitors of Bruton tyrosine kinase. J Hematol Oncol. 2016 Sep 2;9(1):80. doi: 10.1186/s13045-016-0313-y
  • Xiao L, Salem JE, Clauss S, et al. Ibrutinib-mediated atrial fibrillation attributable to inhibition of C-Terminal Src Kinase. Circulation. 2020 Dec 22;142(25):2443–2455. doi: 10.1161/circulationaha.120.049210
  • Chanan-Khan A, Egyed M, Robak T, et al. Randomized phase 3 study of lenalidomide versus chlorambucil as first-line therapy for older patients with chronic lymphocytic leukemia (the ORIGIN trial). Leukemia. 2017 May;31(5):1240–1243. doi: 10.1038/leu.2017.47
  • Goy A, Ramchandren R, Ghosh N, et al. Ibrutinib plus lenalidomide and rituximab has promising activity in relapsed/refractory non-germinal center B-cell-like DLBCL. Blood. 2019 Sep 26;134(13):1024–1036. doi: 10.1182/blood.2018891598
  • Moreno C, Greil R, Demirkan F, et al. First-line treatment of chronic lymphocytic leukemia with ibrutinib plus obinutuzumab versus chlorambucil plus obinutuzumab: final analysis of the randomized, phase III iLLUMINATE trial. Haematologica. 2022 Sep 1;107(9):2108–2120. doi: 10.3324/haematol.2021.279012