Ibrutinib is intended for patients with MCL who have received at least one prior therapy. (FDA Approval Nov 2013). Note that FDA has also approved acalabrutinib for the treatment of adults with mantle cell lymphoma who have received at least one prior therapy in oct 2017.
| Jan 28, 2019 |
FDA Approves Imbruvica (ibrutinib) Plus Obinutuzumab as First Non-Chemotherapy Combination Regimen for Treatment-Naïve Patients with Chronic Lymphocytic Leukemia* |
| Mar 4, 2016 |
FDA Approves ibrutinib for the First-Line Treatment of Chronic Lymphocytic Leukemia |
| Jul 28, 2014 |
FDA Expands Approved Use of ibrutinib for Chronic Lymphocytic Leukemia to treat patients with CLL who carry a deletion in chromosome 17 (17p deletion), which is associated with poor responses to standard treatment for CLL. |
| Feb 12, 2014 |
FDA Approves Imbruvica ibrutinib to Treat Chronic Lymphocytic Leukemia |
*This approval is based on results from the Phase 3 iLLUMINATE study (PCYC-1130).
| Aug 27, 2018 |
FDA Approves ibrutinib Plus Rituximab for Patients with Waldenström’s Macroglobulinemia* |
| Jan 29, 2015 |
FDA Expands Approved Use of ibrutinib for Waldenström’s Macroglobulinemia |
*This approval is based on results from the randomized, double-blind, placebo-controlled iNNOVATE study (PCYC-1127), the largest Phase 3 study of a non-chemotherapy combination in WM patients. The iNNOVATE study evaluated Imbruvica in combination with rituximab versus placebo plus rituximab in 150 patients with either relapsed/refractory (r/r) disease or previously untreated WM. Results from iNNOVATE showed significant improvement in progression-free survival at 30 months and demonstrated the superiority of Imbruvica plus rituximab over rituximab monotherapy in Waldenström's macroglobulinemia.
(FDA) approved ibrutinib for the treatment of patients with relapsed/refractory (R/R) marginal zone lymphoma (MZL) who require systemic therapy and have received at least one prior anti-CD20-based therapy in jan 2017. The approval in MZL is based on data from the Phase 2, open-label, multi-center, single-arm PCYC-1121 study, which evaluated the safety and efficacy of IMBRUVICA in MZL patients who require systemic therapy and have received at least one prior anti-CD20-based therapy.
| Aug 24, 2022 |
FDA Approves Imbruvica (ibrutinib) as First and Only BTKi Treatment for Pediatric Patients with Chronic Graft-Versus-Host Disease after the failure of one or more lines of systemic therapy. * |
| Aug 2, 2017 |
FDA Approves Imbruvica (ibrutinib) for Chronic Graft Versus Host Disease after the failure of one or more treatments. This is the first FDA-approved therapy for the treatment of cGVHD. |
*The new indication is based on results from the Phase 1/2 iMAGINE study, which showed an overall response rate (ORR) through week 25 of 60 percent.
