FDA Approves Checkpoint Therapeutics' Skin Cancer Drug One Year After Rejection
FDA Approves Checkpoint Therapeutics' Skin Cancer Drug One Year After Rejection
The FDA approval comes ahead of its PDUFA date of December 28.On Friday, the FDA approved Checkpoint Therapeutics, Inc.'s (NASDAQ:CKPT) Unloxcyt (cosibelimab-ipdl) for metastatic cutaneous squamous cell carcinoma (cSCC) or locally advanced cSCC who are not candidates for curative surgery or curative radiation.
週五，FDA批准了Checkpoint Therapeutics, Inc.（納斯達克：CKPT）的Unloxcyt（cosibelimab-ipdl），用於治療轉移性皮膚鱗狀細胞癌（cSCC）或局部晚期cSCC，適用於不適合根治性手術或根治性放療的患者。
Unloxcyt is the first and only programmed death ligand-1 (PD-L1) blocking antibody to receive FDA marketing approval for this indication.
Unloxcyt是首個也是唯一一個獲得FDA市場批准用於此適應症的程序性死亡配體-1（PD-L1）阻斷抗體。
The recommended commercial dosage of Unloxcyt is 1,200 mg administered as an intravenous infusion over 60 minutes every three weeks.
推薦的Unloxcyt商業劑量爲1200毫克，給予靜脈輸注，持續60分鐘，每三週一次。
The FDA approval comes ahead of its PDUFA date of December 28.
FDA的批准是在其PDUFA日期之前，日期爲12月28日。
"Today's FDA approval of Unloxcyt – the first marketing approval for our company...This approval marks Checkpoint's transformation to a commercial-stage company, with the opportunity to compete in a U.S. market estimated to exceed $1 billion annually, where we believe Unloxcyt offers a differentiated treatment option versus available therapies," said James Oliviero, President and Chief Executive Officer of Checkpoint.
「今天FDA對Unloxcyt的批准——這是我們公司的首個市場批准……這項批准標誌着Checkpoint的轉型爲商業階段公司，有機會在美國市場競爭，估計年收入超過10億，Unloxcyt提供了與現有療法不同的治療選擇，」Check Point的總裁兼首席執行官James Oliviero說。
Cutaneous squamous cell carcinoma is the second most common type of skin cancer in the U.S., with an estimated annual incidence of approximately 1.8 million cases, according to the Skin Cancer Foundation.
皮膚鱗狀細胞癌是美國第二常見的皮膚癌類型，年發病率約爲180萬例，數據來源於皮膚癌基金會。
While most cases are localized tumors amenable to curative resection, each year, approximately 40,000 cases become advanced, and an estimated 15,000 people in the U.S. die from this disease.
雖然大多數病例是適合進行根治切除的局部腫瘤，但每年大約有40,000例變爲晚期，並且估計有15,000人在美國因這種疾病而死亡。
FDA approval for Unloxcyt was granted based on clinically meaningful objective response rates and duration of response data, as assessed by an independent central review committee from Study CK-301-101.
Unloxcyt的FDA批准是基於獨立中央審查委員會對Ck-301-101研究所評估的臨床有意義的客觀反應率和反應持續時間數據。
Last year, Checkpoint Therapeutics received a complete response letter (CRL) regarding their application for cosibelimab.
去年，Checkpoint Therapeutics 收到了關於他們的 cosibelimab 申請的完全回覆信（CRL）。
The letter pointed out issues related to a third-party manufacturer's inspection, not concerns about the treatment's effectiveness or safety.
信中指出了與第三方製造商檢查相關的問題，而不是對治療效果或安全性的擔憂。
Price Action: CKPT stock is up 3.54% at $3.80 during the premarket session at last check Monday.
價格動態：CKPt 股票在最後檢查週一的盤前交易中上漲了 3.54%，達到 3.80 美元。
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圖片來自shutterstock。
譯文內容由第三人軟體翻譯。
