FDA批准了默克公司的一分钟癌症注射疗法-动脉网

FDA Clears Merck's One-Minute Cancer Shot

benzinga 等信源发布 2025-09-22 13:23

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The U.S. Food and Drug Administration (FDA) on Friday approved

美国食品药品监督管理局（FDA）周五批准了

Merck & Co. Inc.’s

默克公司

MRK

默克公司

Keytruda Qlex

(pembrolizumab and berahyaluronidase alfa-pmph) injection for subcutaneous administration in adults across most solid tumor

(pembrolizumab 和 berahyaluronidase alfa-pmph) 用于成人大多数实体瘤的皮下注射

indications for Keytruda

Keytruda的适应症

。

Berahyaluronidase alfa is a variant of human hyaluronidase developed and manufactured by

贝拉透明质酸酶阿尔法是一种由人类透明质酸酶开发并制造的变体

Alteogen Inc

阿尔特奥根公司

。

Merck expects to have Keytruda Qlex available in the U.S. in late September.

默克公司预计Keytruda Qlex将在9月下旬在美国上市。

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Merck’s Exit Highlights UK Risks Losing Pharma Investment Amid Rising Costs

默克退出凸显英国面临失去制药投资的风险，成本上升加剧了这一问题。

The pivotal trial comparing subcutaneous Keytruda Qlex to IV Keytruda administered every six weeks, each with chemotherapy, was conducted in patients with treatment-naïve metastatic non-small cell lung cancer (NSCLC) with no EGFR, ALK, or ROS1

关键试验比较了皮下注射Keytruda Qlex与每六周一次静脉注射Keytruda，两者均联合化疗，试验对象为初治的转移性非小细胞肺癌（NSCLC）患者，且无EGFR、ALK或ROS1突变。

genomic tumor aberrations

基因组肿瘤畸变

。

In descriptive efficacy analyses, overall response rates (ORR) were similar between Keytruda Qlex and Keytruda (45% vs. 42%). Additionally, no notable differences were observed in progression-free survival (PFS) and overall survival (OS).

在描述性疗效分析中，Keytruda Qlex 和 Keytruda 的总体缓解率 (ORR) 相似（45% 对 42%）。此外，在无进展生存期 (PFS) 和总生存期 (OS) 方面未观察到显著差异。

The effectiveness of Keytruda Qlex for its approved indications was established based on these data and pivotal trial data demonstrating comparable safety with Keytruda, as well as evidence from adequate and well-controlled studies conducted with Keytruda.

基于这些数据和证明与Keytruda安全性相当的关键试验数据，以及使用Keytruda进行的充分且良好对照研究的证据，已确立Keytruda Qlex在其获批适应症中的有效性。

As a subcutaneous injection, Keytruda Qlex may provide added convenience compared to IV Keytruda. It can be given in one minute every three weeks or in two minutes every six weeks, requiring substantially less time to administer than a 30-minute IV infusion of Keytruda.

作为一种皮下注射，Keytruda Qlex可能比静脉注射的Keytruda提供更多的便利性。它可以在每三周进行一次一分钟的注射，或者每六周进行一次两分钟的注射，相较于30分钟的Keytruda静脉输注，所需时间大大减少。

On Friday, the European agency recommended approval for two positive opinions for Keytruda, including a new

欧洲药品管理局周五推荐批准 Keytruda 的两项正面意见，包括一项新的

subcutaneous administration route

皮下给药途径

。

Price Action:

价格行为:

MRK stock is trading lower by 1.23% to $80.51 at last check Monday.

周一最后一次检查时，MRK股票下跌1.23%，交易价格为80.51美元。

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