The Janssen Pharmaceutical Companies of Johnson & Johnson announced the FDA approval of Imbruvica (ibrutinib) in combination with rituximab for the treatment of Waldenström’s macroglobulinemia.
The approval expands the label for Imbruvica in WM beyond its approved use as a monotherapy to include combination use with rituximab. The approval represents the first approved non-chemotherapy combination option for the treatment of WM.
Imbruvica first received FDA approval in WM as a monotherapy in January 2015 via the Breakthrough Therapy Designation pathway, making it the first FDA-approved therapy for the disease. The expanded label marks the ninth FDA approval for Imbruvica since 2013. Imbruvica is a first-in-class Bruton’s tyrosine kinase inhibitor jointly developed and commercialized by Janssen Biotech Inc. and Pharmacyclics LLC, an AbbVie company.
This approval is based on results from the randomized, double-blind, placebo-controlled iNNOVATE study (PCYC-1127), the largest phase III 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 disease or previously untreated WM.
At a median follow up of 26.5 months, a significant improvement in the Independent Review Committee-assessed primary endpoint of progression-free survival was seen with Imbruvica plus rituximab when compared with placebo plus rituximab (30-month PFS rates were 82% vs. 28%, respectively). Patients in the Imbruvica plus rituximab treatment arm experienced an 80% reduction in relative risk of disease progression or death compared with patients treated with placebo plus rituximab (hazard ratio=0.20; confidence interval, 0.11-0.38, p<0.0001).