Section 6 PD-1 / L1 inhibitor! Sanofi is expected to go on sale this year

Source: Wuxi apptec 2018-5-2 today, Sanofi and regeneron pharmaceuticals announced that the U.S FDA has agreed to give priority to the review of its new drug, cemiplimab, for the treatment of metastatic skin squamous cell carcinoma (CSCC) patients who are not suitable for surgery or locally advanced CSCC patients FDA is expected to respond by October 28 this year Skin squamous cell carcinoma (CSCC) is the second most common type of skin cancer in the United States The number of new cases is increasing every year Although early detection of CSCC has a good prognosis, it will become difficult to treat when the cancer is advanced, and the quality of life of the patients will also decline Advanced CSCC is a fatal non melanoma skin cancer that kills about 7000 people a year in the United States However, there is no FDA approved treatment plan for advanced CSCC, and these patients urgently need effective treatment to alleviate the disease Cemiplimab, developed by Sanofi and regeneron, is an in-depth human monoclonal antibody against checkpoint inhibitor PD-1, which is expected to change the current situation of intractable treatment of advanced CSCC It was recognized as a breakthrough therapy by the FDA in September last year In April of this year, the European Drug Administration (EMA) accepted the marketing license application of cemiplimab for patients with metastatic CSCC or locally advanced CSCC who are not suitable for surgery The BLA submission is based on the results of a phase 2 critical, single arm, open label clinical trial empower-cscc1 in advanced CSCC, as well as data from two extended cohorts of advanced CSCC in phase 1 Both studies recruited patients with metastatic CSCC who were not suitable for surgery and patients with locally advanced CSCC The top line results of empower-cscc 1 were published in December last year, and the results of phase 1 extended cohort were published at the annual meeting of the American Society of Clinical Oncology (ASCO) in 2017 The latest results from these two clinical trials will be announced at the upcoming 2018 ASCO annual meeting We hope that this new PD-1 inhibitor can bring effective treatment to CSCC patients Party website