Table 1.
FDA Approved Indications for BTKi Therapy
| Clinical Trial that led to FDA Approval | BTKi | Date of approval | Disease Setting |
|---|---|---|---|
| Chronic Lymphocytic Leukemia | |||
| Byrd 2013 [114] | Ibrutinib | 2/12/14 | Relapsed/Refractory disease |
| Byrd 2014 [15] | Ibrutinib | 7/28/14 | Del(17p) disease |
| Burger 2020 [16] | Ibrutinib | 3/4/16 | Treatment Naive |
| Sharman 2020 [57] Ghia 2020 [115] Byrd 2021 [48] |
Acalabrutinib | 11/21/19 | Treatment Naïve and Relapsed/Refractory disease |
| Tam 2019 [116] | Zanubrutinib | Not FDA approved Included in NCCN guidelines | Treatment Naïve and Relapsed/Refractory disease |
| Mantle Cell Lymphoma | |||
| Wang 2012 [13] | Ibrutinib | 11/13/13 | Relapsed/Refractory disease |
| Wang 2018 [68] | Acalabrutinib | 10/31/17 | Relapsed/Refractory disease |
| Tam 2021 [117] | Zanubrutinib | 11/14/19 | Relapsed/Refractory disease |
| DLBCL | |||
| Wilson 2015 [118] | Ibrutinib | Not FDA approved Included in NCCN guidelines | Relapsed/Refractory non-GCB DLBCL |
| Lymphoplasmacytic Lymphoma | |||
| Treon 2015 [119] | Ibrutinib | 1/29/15 | Relapsed/Refractory disease |
| Dimopoulos 2017 [120] | Ibrutinib | 8/27/18 | Treatment Naïve and Relapsed/Refractory disease, with rituximab |
| Tam 2020 [121] | Zanubrutinib | 9/1/21 | Treatment Naïve and Relapsed/Refractory disease |
| Marginal Zone Lymphoma | |||
| Noy 2020 [122] | Ibrutinib | 1/19/17 | Relapsed/Refractory Disease |
| Opat 2020 [123] | Zanubrutinib | 9/15/21 | Relapsed/Refractory disease |