A supplemental New Drug Application (sNDA) for ibrutinib (Imbruvica; Pharmacyclics and Janssen Biotech) to be used in combination with rituximab (Rituxan; Genentech and Biogen) to treat Waldenström’s macroglobulinemia (WM), has been accepted for Priority Review by the Food and Drug Administration (FDA).
Ibrutinib is a first-in-class, oral therapy that blocks the Bruton’s tyrosine kinase protein. It is currently approved as monotherapy in WM, a rare, incurable form of non-Hodgkin’s lymphoma.
The sNDA is supported by data from the Phase 3 iNNOVATE (PCYC-1127) trial which assessed ibrutinib in combination with rituximab vs rituximab alone in 150 patients with previously untreated and relapsed/refractory WM. Results showed that the progression-free survival rate was 82% in the ibrutinib-rituximab combination group vs 28% in the placebo-rituximab group (hazard ratio, 0.20; P<0.01). Grade 3 or higher adverse events that occurred more frequently with ibrutinib–rituximab than with placebo–rituximab included atrial fibrillation (12% vs 1%) and hypertension (13% vs 4%).
“These promising findings build on our commitment to exploring the full potential of Imbruvica alone and in combination with other treatments. If approved, this chemotherapy-free combination will provide another treatment opportunity for patients living with this rare disease,” said Thorsten Graef, MD, PhD, Head of Clinical Development at Pharmacyclics LLC, an AbbVie company.
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