產業訊息
美國FDA核准AstraZeneca新藥Lumoxiti用於治療髮狀細胞白血病(HCL)
2018-09-14

根據路透社報導,美國FDA週四核准AstraZeneca的新藥Lumoxiti (moxetumomab pasudotox-tdfk),用於治療已經接受至少兩種全身治療的復發或難治性髮狀細胞白血病(Hairy cell leukemia, HCL)成年患者。Lumoxiti 的III期臨床試驗結果顯示,接受Lumoxiti治療的患者有75%達到了整體反應(95%信賴區間[CI]:64,84); 30%具有完全反應(95%信賴區間[CI]:20,41)。

三期臨床試驗結果摘要:

Efficacy Measure Result %, (95% CI)
Durable Complete Response Ratea,b 30% (20, 41)
Overall Response Ratec 75% (64, 84)
Complete Responsed 41% (30, 53)
Partial Responsee 34% (24, 45)
Hematologic Remissionb 80%

 

a   Durable complete response is defined as patients who achieved complete response with hematologic remission for a duration of more than 180 days
b   Hematologic remission is defined as hemoglobin > 11g/dL, neutrophils > 1500/mm3, and platelets > 100,000/mm3 without transfusions or growth factor for at least 4 weeks
c   Overall response rate is defined as best overall response of complete response or partial response
d   Complete response is defined as clearing of the bone marrow of hairy cells by routine Hematoxylin and Eosin stain, radiologic resolution of preexisting lymphadenopathy and/or organomegaly, and hematologic remission
e   Partial response is defined as ≥ 50% decrease or normalization (< 500/mm3) in peripheral blood lymphocyte count, reduction of pre-existing lymphadenopathy and/or organomegaly, and hematologic remission

 

AstraZeneca全球腫瘤業務執行副總裁Dave Fredrickson表示:“ 美國FDA核准Lumoxiti對於患有髮狀細胞白血病的人來說是一個重要的里程碑,髮狀細胞白血病是一種罕見的血癌,可導致嚴重和危及生命的疾病。對於患者而言,這項核准是20多年來首個獲FDA核准用於治療該疾病的藥物。“

參與該三期試驗的美國國家癌症研究所研究員Robert J. Kreitman博士表示,許多髮狀細胞白血病患者可透過現有治療獲得緩解,但30%至40%患者在首次治療後5至10年會復發,Lumoxiti是一項有前景的HCL非化療藥物,可解決醫生及其患者未滿足的醫療需求。“

髮狀細胞白血病是一種起源於淋巴系統的惡性疾病,也是一種發生於老年的罕見疾病,每年大約有1000人被診斷患有HCL。在顯微鏡下,這種白血病細胞有特殊的細胞質突出物,狀似毛髮,因而得名。HCL可導致嚴重疾病,包括感染、出血和貧血。

(生策會)

 

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