The approval is the first for a chemotherapy-free treatment for adults with Waldenström's macroglobulinemia.
Waldenström's macroglobulinemia (WM) is a rare form of non-Hodgkin's lymphoma (NHL), with approximately 2800 new cases reported in the US each year. WM is currently incurable and there are few treatment options. This blood cancer generally occurs in the bone marrow of older adults, but the lymph nodes and spleen can also be affected.
IMBRUVICA® (ibrutinib) is one drug that has been approved (in January 2015) by the US Food and Drug Adminsitration (FDA) for the treatment of WM. It is a first-in-class Bruton's tyrosine kinase (BTK) inhibitor jointly developed and commercialized by Pharmacyclics LLC, an AbbVie company, and Janssen Biotech, Inc.
FDA recently approved a combination therapy of IMBRUVICA with RITUXAN® (rituximab) for the treatment of adult patients with WM, expanding its prescribing information. This approval is the first for a chemotherapy-free combination treatment specifically indicated for WM.
The approval was supported by data obtained in the Phase 3 iNNOVATE (PCYC-1127), which compared the efficacy of IMBRUVICA in combination with rituximab, to that of rituximab alone, in 150 patients with previously untreated and relapsed/refractory WM. The combination treatment was shown to demonstrate a significant improvement in progression-free survival. The combination therapy also provided a significant reduction in the relative risk of disease progression or death.