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.
美國食品藥品管理局週五批准了Checkpoint Therapeutics, Incs（納斯達克股票代碼：CKPT）Unloxcyt（cosibelimab-ipdl）用於治療轉移性皮膚鱗狀細胞癌（cSCC）或不適合接受治療性手術或治療性放射治療的局部晚期CSCC。
Unloxcyt is the first and only programmed death ligand-1 (PD-L1) blocking antibody to receive FDA marketing approval for this indication.
Unloxcyt是第一個也是唯一一種獲得美國食品藥品管理局該適應症上市批准的程序性死亡配體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.
Unloxcyt的推薦商業劑量爲1,200 mg，靜脈輸液，每三週靜脈注射60分鐘。
The FDA approval comes ahead of its PDUFA date of December 28.
美國食品和藥物管理局的批准是在其PDUFA日期（12月28日）之前獲得的。
"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.
Checkpoint總裁兼首席執行官詹姆斯·奧利維羅表示：「今天美國食品藥品管理局批准Unloxcyt——這是我們公司的首次上市許可... 這一批准標誌着Checkpoint向商業階段的公司轉型，有機會在估計每年超過10億美元的美國市場中競爭，我們認爲Unloxcyt提供了與現有療法相比差異化的治療選擇。」
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.
根據皮膚癌基金會的數據，皮膚鱗狀細胞癌是美國第二常見的皮膚癌類型，估計年發病率約爲180萬例。
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.
雖然大多數病例是局部腫瘤，可以進行治療性切除，但每年約有40,000例病例晚期，估計美國有15,000人死於這種疾病。
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.
根據Ck-301-101研究的獨立中央審查委員會的評估，美國食品藥品管理局對Unloxcyt的批准是根據具有臨床意義的客觀反應率和緩解持續時間數據批准的。
Last year, Checkpoint Therapeutics received a complete response letter (CRL) regarding their application for cosibelimab.
去年，Checkpoint Therapeutics收到了一份關於其申請cosibelimab的完整回覆信（CRL）。
The letter pointed out issues related to a third-party manufacturer's inspection, not concerns about the treatment's effectiveness or safety.
這封信指出了與第三方製造商檢查有關的問題，而不是對治療有效性或安全性的擔憂。
Price Action: CKPT stock is up 3.54% at $3.80 during the premarket session at last check Monday.
價格走勢：在週一最後一次盤前交易中，cKPT股價上漲3.54％，至3.80美元。
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Photo via Shutterstock.
照片來自 Shutterstock。
