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Biologics by McKesson's RYTELOTM, FDA Gets Approval For Treatment Of Patients With Low- To Intermediate-1 Risk Myelodysplastic Syndromes With Transfusion-Dependent Anemia

Biologics by McKesson's RYTELOTM, FDA Gets Approval For Treatment Of Patients With Low- To Intermediate-1 Risk Myelodysplastic Syndromes With Transfusion-Dependent Anemia

麥克森的RYTELOTM生物製品獲得FDA批准,用於治療低至中度-1風險的依賴輸血的貧血骨髓增生異常綜合徵患者。
Benzinga ·  09/09 20:06

Biologics by McKesson, an independent specialty pharmacy specializing in oncology and rare disease areas, was selected by Geron Corporation as a limited specialty pharmacy provider for RYTELOTM (imetelstat) for the treatment of adult patients with low- to intermediate-1 risk myelodysplastic syndromes (MDS) with transfusion-dependent anemia requiring four or more red blood cell units over eight weeks who have not responded to, have lost response to, or are ineligible for erythropoiesis-stimulating agents (ESA).

McKesson的生物製劑是一家專門研究腫瘤學和罕見病領域的獨立專業藥房,被Geron Corporation選爲RyteloTM(imetelstat)的有限專業藥房提供商,該藥用於治療患有低至中等風險骨髓增生異常綜合徵(MDS)的成年患者,這些患者在八週內需要四個或更多紅細胞單位,但沒有反應,但沒有反應或沒有資格使用促紅細胞生成藥物(ESA)。

RYTELO, approved by the U.S. Food and Drug Administration (FDA) on June 6, 2024, is a first-in-class telomerase inhibitor. RYTELO binds to the template region of the RNA component of human telomerase (hTR), inhibiting telomerase enzymatic activity and preventing telomere binding.1 Increased telomerase activity has been reported in MDS malignant stem and progenitor cells.

RYTELO 於 2024 年 6 月 6 日獲得美國食品藥品監督管理局 (FDA) 的批准,是同類首創的端粒酶抑制劑。RYTELO 與人端粒酶 (hTR) 的 RNA 成分的模板區域結合,抑制端粒酶活性並防止端粒結合。1 據報道,MDS 惡性幹細胞和祖細胞中端粒酶活性增加。

譯文內容由第三人軟體翻譯。


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