2018年9月29日,美国食品和药物管理局（FDA）批准Libtayo（cemiplimab）治疗晚期皮肤鳞状细胞癌患者。大多数人可以通过手术或放射治疗，但在某些情况下，癌症会变得更先进，这些治疗可能不再是选择。
  Libtayo是FDA批准的第一种专门用于皮肤晚期鳞状细胞癌的药物。它是一种叫做检查点抑制剂的免疫治疗药物。它通过在某些免疫细胞上阻断一种叫做PD-1的蛋白质起作用。这种蛋白质有助于癌细胞避免被身体的免疫系统发现和破坏。阻断PD-1蛋白有助于免疫系统识别癌细胞并攻击它们。Libtayo是3 次免疫抑制剂检查站针对被FDA批准用于治疗多种不同癌症类型的PD-1途径。
  FDA批准了2项临床试验的结果，其中涉及108名皮肤晚期鳞状细胞癌患者。所有患者都知道他们被给予了Libtayo。这些研究旨在测量客观反应率，即在给予Libtayo后肿瘤缩小或消失的参与者的百分比。结果显示客观反应率为47％。
  FDA根据其突破性治疗和优先审查计划批准了该计划，旨在加快批准用于治疗严重疾病的药物。
  Libtayo静脉注射（通过静脉注射）。最常见的副作用包括疲劳，皮疹和腹泻。它还可以使免疫系统攻击正常的器官和组织，并影响它们的工作方式。这些可包括肺，肠，肝，激素腺（肾上腺，甲状腺）和肾。在某些情况下，反应可能很严重并且会危及生命。如果一名妇女怀孕并服用Litayo，该药物可能对发育中的胎儿造成伤害。
LIBTAYO® is a programmed death receptor-1 (PD-1) blocking antibody indicated for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation.
Important Safety Information and Indication
Warnings and Precautions
Severe and Fatal Immune-Mediated Adverse Reactions
Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue and usually occur during treatment; however, they can also occur after discontinuation. Early identification and management are essential to ensuring safe use of PD-1–blocking antibodies. Monitor for symptoms and signs of immune-mediated adverse reactions. eva luate clinical chemistries, including liver tests and thyroid function tests, at baseline and periodically during treatment. Institute medical management promptly to include specialty consultation as appropriate.
In general, withhold LIBTAYO for Grade 3 or 4 and certain Grade 2 immune-mediated adverse reactions. Permanently discontinue LIBTAYO for Grade 4 and certain Grade 3 immune-mediated adverse reactions. For Grade 3 or 4 and certain Grade 2 immune-mediated adverse reactions, administer corticosteroids (1 to 2 mg/kg/day prednisone or equivalent) or other appropriate therapy until improvement to Grade 1 or less followed by a corticosteroid taper over 1 month. Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reaction is not controlled with corticosteroids. Institute hormone replacement therapy for endocrinopathies as warranted.
Immune-mediated pneumonitis: Immune-mediated pneumonitis occurred in 2.4% of 534 patients receiving LIBTAYO, including Grade 5 (0.2%), Grade 3 (0.7%), and Grade 2 (1.3%). Pneumonitis led to permanent discontinuation of LIBTAYO in 1.3% of patients. Systemic corticosteroids were required in all patients with pneumonitis, including 85% who received prednisone ≥40 mg/day or equivalent. Pneumonitis resolved in 62% of patients. Withhold LIBTAYO for Grade 2, and permanently discontinue for Grade 3 or 4. Resume in patients with complete or partial resolution (Grade 0 to 1) after corticosteroid taper.
Immune-mediated colitis: Immune-mediated colitis occurred in 0.9% of 534 patients receiving LIBTAYO, including Grade 3 (0.4%) and Grade 2 (0.6%). Colitis led to permanent discontinuation of LIBTAYO in 0.2% of patients. Systemic corticosteroids were required in all patients with colitis, including 60% who received prednisone ≥40 mg/day or equivalent. Colitis resolved in 80% of patients. Withhold LIBTAYO for Grade 2 or 3, and permanently discontinue for Grade 4. Resu