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.
周五，FDA批准了Checkpoint Therapeutics, Inc.（纳斯达克：CKPT）的Unloxcyt（cosibelimab-ipdl），用于治疗转移性皮肤鳞状细胞癌（cSCC）或局部晚期cSCC，适用于不适合根治性手术或根治性放疗的患者。
Unloxcyt is the first and only programmed death ligand-1 (PD-L1) blocking antibody to receive FDA marketing approval for this indication.
Unloxcyt是首个也是唯一一个获得FDA市场批准用于此适应症的程序性死亡配体-1（PD-L1）阻断抗体。
The recommended commercial dosage of Unloxcyt is 1,200 mg administered as an intravenous infusion over 60 minutes every three weeks.
推荐的Unloxcyt商业剂量为1200毫克，给予静脉输注，持续60分钟，每三周一次。
The FDA approval comes ahead of its PDUFA date of December 28.
FDA的批准是在其PDUFA日期之前，日期为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对Unloxcyt的批准——这是我们公司的首个市场批准……这项批准标志着Checkpoint的转型为商业阶段公司，有机会在美国市场竞争，估计年收入超过10亿，Unloxcyt提供了与现有疗法不同的治疗选择，”Check Point的总裁兼首席执行官James Oliviero说。
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.
皮肤鳞状细胞癌是美国第二常见的皮肤癌类型，年发病率约为180万例，数据来源于皮肤癌基金会。
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.
虽然大多数病例是适合进行根治切除的局部肿瘤，但每年大约有40,000例变为晚期，并且估计有15,000人在美国因这种疾病而死亡。
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批准是基于独立中央审查委员会对Ck-301-101研究所评估的临床有意义的客观反应率和反应持续时间数据。
Last year, Checkpoint Therapeutics received a complete response letter (CRL) regarding their application for cosibelimab.
去年，Checkpoint Therapeutics 收到了关于他们的 cosibelimab 申请的完全回复信（CRL）。
The letter pointed out issues related to a third-party manufacturer's inspection, not concerns about the treatment's effectiveness or safety.
信中指出了与第三方制造商检查相关的问题，而不是对治疗效果或安全性的担忧。
Price Action: CKPT stock is up 3.54% at $3.80 during the premarket session at last check Monday.
价格动态：CKPt 股票在最后检查周一的盘前交易中上涨了 3.54%，达到 3.80 美元。
- Novo Nordisk's Ozempic Potentially Linked To Rare Vision Loss Risk, But Absolute Risk Is Low: Study
- 诺和诺德的 Ozempic 潜在与罕见视力损失风险相关，但绝对风险较低：研究
Photo via Shutterstock.
图片来自shutterstock。
