食品和药物管理局批准了Merck对某些肿瘤的下属KEYTRUDA, 提供更快、方便的剂量,其效果和安全性与第四版相同。 The FDA approved Merck’s subcutaneous KEYTRUDA for certain tumors, offering faster, convenient dosing with similar effectiveness and safety as the IV version.

美国食品和药物管理局批准了Merck的KEYTRUDA QLEX,这是用于12岁和12岁以上成人和患有某些以前通过静脉注射KEYTRUDA治疗的固态肿瘤的儿童用Berahyaluronidase alfa-pmph 进行的一种次切配方。 The U.S. FDA has approved Merck’s KEYTRUDA QLEX, a subcutaneous formulation of pembrolizumab with berahyaluronidase alfa-pmph, for adults and children aged 12 and older with certain solid tumors previously treated with intravenous KEYTRUDA. 根据第三阶段试验的结果,新方案仅需要1-2分钟来实施,为患有转移性非小型细胞肺癌的第四版病人提供类似的药物水平、反应率和存活率。 The new option, which takes just 1–2 minutes to administer, offers comparable drug levels, response rates, and survival outcomes to the IV version in patients with metastatic non-small cell lung cancer, based on results from a phase 3 trial. 安全情况相似,免疫媒介反应和其他风险仍然存在。 Safety profiles were similar, with immune-mediated reactions and other risks still present. 这种亚切形式可以改善治疗便利,减少在临床环境中花费的时间。 The subcutaneous form may improve treatment convenience and reduce time spent in clinical settings. 剂量为每3周 (395 mg/ 4, 800 单位) 或每6周 (790 mg/ 9, 600 单位). Dosing is every 3 weeks (395 mg/4,800 units) or every 6 weeks (790 mg/9,600 units). Merck计划在2025年9月底前在美国推出该药物。 Merck plans to launch the drug in the U.S. by late September 2025.