FDA Approves Geron's First Commercial Drug, Competes With Bristol Myers Squibb's Blood Cancer Drug
FDA Approves Geron's First Commercial Drug, Competes With Bristol Myers Squibb's Blood Cancer Drug
On Thursday, the FDA approved Geron Corporation's (NASDAQ:GERN) Rytelo (imetelstat) for adult patients with low-to intermediate-1 risk myelodysplastic syndromes (MDS) with transfusion-dependent anemia.
FDA已批准Geron公司（納斯達克：傑龍）的Rytelo（imetelstat）用於低到中度1風險的髓系增生綜合症（MDS）成人患者，伴隨輸血依賴性貧血。
The approval covers patients requiring four or more red blood cell units over eight weeks who have not responded to or have lost response to or are ineligible for erythropoiesis-stimulating agents.
該批准涵蓋了需要在八週內輸注四個或更多紅細胞單位的患者，他們未對促紅細胞生成素類藥物作出反應或出現反應喪失或不符合資格。
In March, by a 12-to-2 margin, the FDA adcomm panel voted in favor of the benefits of imetelstat, stating that the associated risks and toxicities of the treatment appear to be manageable.
3月份，FDA的12名成員中有10名成員對imetelstat的益處投了贊成票，認爲該治療的相關風險和毒性是可管理的。
The FDA approval is based on IMerge Phase 3 trial results.
FDA的批准基於IMerge第三期臨床試驗結果。
The IMerge trial met its primary and key secondary endpoints, with Rytelo demonstrating significantly higher rates of red blood cell transfusion independence (RBC-TI) versus placebo for at least eight consecutive weeks (Rytelo 39.8%; placebo 15.0%) and at least 24 weeks (Rytelo 28.0%; placebo 3.3%.
IMerge試驗達到了主要和關鍵的次要終點。對於連續至少八個星期（Rytelo 39.8％；安慰劑15.0％）和至少24個星期（Rytelo 28.0％；安慰劑3.3％），Rytelo表現出顯着更高的紅細胞輸注獨立率（RBC-TI）。
RBC-TI was durable and sustained in the Rytelo-treated population, with a median RBC-TI duration for 8-week responders and 24-week responders of approximately one year and 1.5 years, respectively.
在Rytelo治療人群中，RBC-TI持久且持續，8周反應者和24周反應者的中位數RBC-TI持續時間分別爲一年左右和1.5年左右。
In an exploratory analysis of Rytelo-treated patients achieving ≥8-week RBC-TI, median increases in hemoglobin were 3.6 g/dL for Rytelo and 0.8 g/dL for placebo.
在Rytelo治療的患者中進行了探索性分析，8周RBC-TI的中位數血紅蛋白增加值爲Rytelo 3.6 g/dL，安慰劑0.8 g/dL。
Clinically meaningful efficacy results were observed across key MDS subgroups irrespective of ring sideroblast status, baseline transfusion burden, and IPSS risk category.
在關鍵的MDS亞組中觀察到了臨床意義的功效結果，不考慮磷酸鐵夾雜體狀態、基線輸血負擔和IPSS風險類別。
Imetelstat is Geron's first commercial treatment in the market. It competes with Bristol Myers Squibb Co's (NYSE:BMY) Reblozyl (luspatercept-aamt), which received an FDA label expansion last year for the same disease indication.
Imetelstat是Geron公司在市場上的首個商業治療方案。它與Bristol Myers Squibb Co（紐交所：BMY）的Reblozyl（luspatercept-aamt）競爭，後者去年擴大了相同疾病指示的FDA標籤。
Last January, Geron's CEO John Scarlett told Reuters that the company anticipates a peak market potential of $1.2 billion in the United States and some key EU countries by 2030.
去年1月，Geron公司的首席執行官John Scarlett告訴路透社，該公司預計到2030年美國和一些歐盟主要國家的市場潛力將達到12億美元。
Price Action: GERN shares are up 25.4% at $4.88 at the last check on Friday.
GERN股票上漲25.4％，最新價格爲4.88美元。
譯文內容由第三人軟體翻譯。