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FDA Grants Ibrutinib/Rituximab Priority Review for Waldenstrom Macroglobulinemia

Jason M. Broderick @jasoncology
Published: Monday, Jun 25, 2018

The FDA has granted a priority review to a supplemental new drug application (sNDA) for ibrutinib (Imbruvica) for use in combination with rituximab (Rituxan) as a treatment option across all lines of therapy for patients with Waldenström macroglobulinemia, according Pharmacyclics (AbbVie) and Janssen Biotech, the codevelopers of ibrutinib.

The median number of prior therapies in patients with relapsed disease was 2 (range, 1-6), and 85% had prior rituximab. Patients who had prior rituximab had to have achieved at least a minimal response to their last rituximab-based treatment.


Patients received IV rituximab at 375 mg/m2 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.

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