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FDA approves Imbruvica plus Rituxan for Waldenström’s macroglobulinemia
The FDA approved ibrutinib in combination with rituximab for the treatment of adults with Waldenström’s macroglobulinemia.
Ibrutinib (Imbruvica; Pharmacyclics/AbbVie, Janssen Biotech) — a first-in-class Bruton tyrosine kinase inhibitor — also is indicated as a single agent for the treatment of Waldenström’s macroglobulinemia.
The FDA based this approval of ibrutinib plus rituximab on results from the phase 3 iNNOVATE trial. This analysis included 150 patients with relapsed/refractory and treatment-naive Waldenström’s macroglobulinemia who were randomly assigned to ibrutinib 420 mg or placebo. All patients received IV rituximab 375 mg/m2 once weekly for 4 consecutive weeks, followed by a second 4-week 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 and published in The New England Journal of Medicine.
Median follow-up was 26.5 months.
Eighty-two percent of the ibrutinib plus rituximab group achieved 30-month 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).
“The iNNOVATE study demonstrated persuasive clinical evidence supporting the efficacy of Imbruvica plus rituximab in Waldenström’s macroglobulinemia,” Meletios A. Dimopoulos, MD, professor and chairman of the department of clinical therapeutics at National and Kapodistrian University of Athens School of Medicine in Greece, said in a press release. “This approval is a significant milestone for the Waldenström’s macroglobulinemia community who have limited treatment options.”
The most common adverse reactions of any grade occurring among patients who received the combination included bruising (37%), musculoskeletal pain (35%), hemorrhage (32%), diarrhea (28%), rash (24%), arthralgia (24%), nausea (21%) and hypertension (20%).
This approval marks the first chemotherapy-free combination regimen indicated for this disease.
“Ibrutinib has significantly advanced the treatment of Waldenström’s macroglobulinemia. The approval of ibrutinib and rituximab has added a new option for many Waldenström’s patients,” Steven P. Treon, MD, PhD, director of the Bing Center for Waldenström's Macroglobulinemia at Dana-Farber Cancer Institute and associate professor at Harvard Medical School, said in the release.
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.