欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Libtayo
适用类别Human
治疗领域Carcinoma, Squamous Cell
通用名/非专利名称cemiplimab
活性成分cemiplimab
产品号EMEA/H/C/004844
患者安全信息No
许可状态Authorised
ATC编码L01XC33
是否额外监管No
是否仿制药或hybrid药物No
是否生物类似药No
是否附条件批准No
是否特殊情形No
是否加速审评No
是否罕用药No
上市许可日期2019/06/28
上市许可开发者/申请人/持有人Regeneron Ireland Designated Activity Company (DAC)
人用药物治疗学分组Antineoplastic agents
兽用药物治疗学分组
审评意见日期2019/04/26
欧盟委员会决定日期2025/11/17
修订号22
治疗适应症Cutaneous Squamous Cell Carcinoma Libtayo as monotherapy is indicated for the treatment of adult patients with metastatic or locally advanced cutaneous squamous cell carcinoma (mCSCC or laCSCC) who are not candidates for curative surgery or curative radiation. Libtayo as monotherapy is indicated for the adjuvant treatment of adult patients with CSCC at high risk of recurrence after surgery and radiation (see section 5.1 for selection criteria).  Basal Cell Carcinoma Libtayo as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic basal cell carcinoma (laBCC or mBCC) who have progressed on or are intolerant to a hedgehog pathway inhibitor (HHI). Non-Small Cell Lung Cancer Libtayo as monotherapy is indicated for the first-line treatment of adult patients with non-small cell lung cancer (NSCLC) expressing PD-L1 (in ? 50% tumour cells), with no EGFR, ALK or ROS1 aberrations, who have: locally advanced NSCLC who are not candidates for definitive chemoradiation, or metastatic NSCLC. Libtayo in combination with platinum?based chemotherapy is indicated for the first?line treatment of adult patients with NSCLC expressing PD-L1 (in ? 1% of tumour cells), with no EGFR, ALK or ROS1 aberrations, who have: locally advanced NSCLC who are not candidates for definitive chemoradiation, or metastatic NSCLC. Cervical Cancer Libtayo as monotherapy is indicated for the treatment of adult patients with recurrent or metastatic cervical cancer and disease progression on or after platinum-based chemotherapy.
适用物种
兽用药物ATC编码
首次发布日期2019/07/05
最后更新日期2025/12/10
产品说明书https://www.ema.europa.eu/en/documents/product-information/libtayo-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/libtayo
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