(Lymphoma) FDA Approves Brukinsa for Waldenström's Macroglobulinemia
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هذه المقالة ملخص لمعلومات طبية دولية وليست نصيحة طبية، ولا يمكن أن تحل محل تشخيص طبيبك المعالج أو خطة العلاج. المعلومات المعروضة مجمّعة من منشورات عامة وبيانات رسمية لكبرى المؤسسات الطبية اليابانية؛ وتختلف ملاءمة ونتائج أي علاج من مريض لآخر ويجب أن يقيّمها طبيب مؤهل لكل حالة على حدة.
- September 7, 2021
- 1 min read
On August 31, 2021, the U.S. Food and Drug Administration (FDA) approved Brukinsa (zanubrutinib) for the treatment of Waldenström's macroglobulinemia (WM).
This approval was based on the ASPEN clinical trial (NCT03053440), a randomized, active-controlled, open-label study in patients with WM harboring MYD88 L265P mutation, divided into two cohorts. Cohort 1 patients (n=201) were randomized 1:1 to Brukinsa (160 mg twice daily) or ibrutinib (420 mg once daily) until disease progression or intolerable adverse effects. Cohort 2 enrolled patients with wild-type MYD88, or unknown MYD88 mutation status (n=26 and n=2, respectively), and received Brukinsa (160 mg twice daily).
The efficacy data supporting this approval were based on criteria established at the 6th International Workshop on Waldenström's Macroglobulinemia, which incorporated response assessments above IRC thresholds and included duration of response as an additional efficacy endpoint.
Results:
In Cohort 1, the Brukinsa arm achieved an objective response rate (ORR) of 77.5% and a 12-month duration of response rate of 94.4%. In Cohort 2, the ORR was 50%.
Safety:
The most common adverse reactions (including laboratory abnormalities, ≥20%) in the Brukinsa arm included neutropenia, upper respiratory tract infection, thrombocytopenia, rash, hemorrhage, musculoskeletal pain, decreased hemoglobin, bruising, diarrhea, pneumonia, and cough.
Recommended dosing: Brukinsa 160 mg orally twice daily or 320 mg once daily.
Source: https://www.cancerit.jp/70053.html
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هل تفكر في تلقّي العلاج في اليابان؟ هل تحتاج إلى معلومات ومساعدة؟
نساعدك في تنظيم المعلومات اللازمة للسفر الطبي إلى اليابان، والتواصل مع المؤسسات الطبية اليابانية، وترتيب استشارة رأي ثانٍ.الاستشارة الأولى مجانية؛ سيساعدك المستشار على توضيح الخطوات التالية.
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