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FDA grants priority review to Imbruvica-Rituxan combination for Waldenström’s macroglobulinemia
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The FDA granted priority review to the supplemental new drug application for ibrutinib in combination with rituximab for the treatment of patients with Waldenström’s macroglobulinemia, according to the manufacturer.
Ibrutinib (Imbruvica; Pharmacyclics, Janssen) — a Bruton tyrosine kinase inhibitor —is indicated for the monotherapy treatment of patients with Waldenström's macroglobulinemia.
The FDA based the priority review designation for ibrutinib plus rituximab (Rituxan; Genentech, Biogen) on the phase 3 iNNOVATE study. This analysis assessed 150 patients with relapsed/refractory and treatment-naive Waldenström’s macroglobulinemia.
Researchers randomly assigned patients to ibrutinib 420 mg or placebo. All patients received IV rituximab 375 mg/m2 once weekly for four consecutive weeks, followed by a second four-weekly rituximab course after a 3-month interval.
PFS served as the primary endpoint.
As HemOnc Today previously reported, results from this study were presented at ASCO Annual Meeting, as well as in The New England Journal of Medicine.
At 30 months, 82% of the combined group achieved PFS compared with 28% of the placebo group (HR for progression or death = 0.2; 96% CI, 0.11-0.38). Ibrutinib plus rituximab induced a higher rate of major response than placebo plus rituximab (72% vs. 32%; P < .001).
“We are excited about the data from the phase 3 iNNOVATE study, which indicate that Imbruvica plus rituximab was able to improve PFS, vs. rituximab alone, across all lines of therapy and Waldenström's macroglobulinemia patient subgroups that were studied,” Thorsten Graef, MD, PhD, head of clinical development at Pharmacyclics, an AbbVie company, said in a press release. “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, which continues to have very limited treatment options.”
Ibrutinib alone is also indicated for the treatment of patients with chronic lymphocytic leukemia, small lymphocytic lymphoma, previously treated mantle cell lymphoma, previously treated marginal zone lymphoma and previously treated chronic graft-versus-host disease.