EU grants Libtayo ® (cemiplimab) listing license for treatment of CSCC adult patients

recently, Sanofi and Regeneration announced that the European Union has granted Libtayo ® a conditional listing license for the treatment of adult patients with metastatic or localized advanced skin squamous cell carcinoma (CSCC)Libtayo is an all-human monoclonal antibody for immunocheckpoint receptor programocellular death protein-1 (PD-1) and is the only late-stage CSCC treatment approved by the European UnionThe APPROVAL of the EMPOWER-CSCC-1EU is based on data on the open label, multi-center, non-random phase 2test(http://EMPOWER-CSCC-1 data, supported by two CSCC extended queues from multi-center, open label, and non-random phase 1 trialsThese trials provide the largest forward-looking clinical data set to date for evaluating systemic therapy in patients with advanced CSCCresults showed that 47 percent of 108 CSCC patients had a reduced tumor volume and 61 percent of patients had a 6 months or more response after 8.9 months of median follow-upThe specific response rate for metastatic cancer was 47%, including a 5% full responseAbout Libtayo
Libtayo's recommended dose is 350 mg per 3 weeks, administered through 30 minutes of intravenous infusionTreatment can continue until the disease progresses or is not acceptableLibtayo was approved by theFDA(http:// in 2018 for the treatment of patients with advanced CSCC In the United States, Libtayo's generic name is cemiplimab-rwlc 　　Libtayo is also conducting research in auxiliary and new auxiliary trials of CSCC, as well as in potential registration trials for non-small cell lung, base cell carcinoma and cervical cancer other studies include clinical trials of head and neck squamous cell carcinoma, melanoma, colorectal cancer, prostate cancer, multiple myeloma, Hodgkin's lymphoma and non-Hodgkin's lymphoma These trials are designed to study Libtayo as a monotherapy or in combination with conventional treatments such as chemotherapy