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FDA Approves Ibrutinib/Rituximab for Waldenstrom Macroglobulinemia

Jason M. Broderick @jasoncology
Published: Monday, Aug 27, 2018

The FDA has approved ibrutinib (Imbruvica) for use in combination with rituximab (Rituxan) as a treatment option across all lines of therapy for patients with Waldenström macroglobulinemia.

 once weekly for 4 straight weeks, followed by another 4-week rituximab course after a 3-month interval. Ibrutinib (420 mg) or placebo were taken once daily continuously. PFS was the primary endpoint, with secondary endpoints including overall response rate (ORR), hematological improvement measured by hemoglobin, time-to-next treatment, overall survival (OS), and safety.


The PFS benefit with the combination was observed across key subgroups, including previously untreated patients (HR, 0.34; 95% CI, 0.12-0.95), relapsed patients (HR, 0.17; 95% CI, 0.08-0.36), MYD88L265P/CXCR4-mutation wild-type (WT; HR, 0.17; 95% CI, 0.06-0.49), MYD88L265P/CXCR4WHIM (HR, 0.24; 95% CI, 0.09-0.66), and MYD88WT/CXCR4-mutation WT (HR, 0.21; 95% CI, 0.04-1.08). 

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