FDA grants Sanofi a new inhibitor breakthrough therapy

[industry trends of China Pharmaceutical network] on September 9, Sanofi and regeneron pharmaceuticals announced that the US FDA granted its PD-1 inhibitor, cemiplimab (also known as regn2810), a breakthrough therapy, which is suitable for adult patients with metastatic skin squamous cell carcinoma (CSCC) and local advanced and unresectable CSCC CSCC is the second most fatal skin cancer after melanoma Early detection of CSCC has a good prognosis, but it will become very difficult to treat if it progresses to the late stage Advanced patients will be disfigured by multiple surgical removal of CSCC tumors located in the head, neck and other parts Cemiplimab is a PD-1 inhibitor under development, which is expected to change the status quo of difficult treatment of advanced CSCC In June, early data released by the two companies at the annual meeting of the American Society of Clinical Oncology (ASCO) showed that cemiplimab could improve the overall remission rate (ORR) of CSCC patients to 46.2% and the disease control rate to 69.2% These data are from two extended cohorts in phase 1 clinical trials, including 26 patients with advanced CSCC Currently, empower-cscc1 phase 2 clinical trial is recruiting patients The drug has obtained the fast track qualification issued by FDA The two companies plan to submit a biopharmaceutical license application for cemiplimab in early 2018 The FDA's decision could speed up the development and review of the drug for a deadly disease "CSCC is one of the cancers with high mutation rate, which may lead to the result of this study - high response rate of solid tumor to PD-1 antibody These results are promising, indicating that PD-1 pathway is an important therapeutic target for these patients, "said Dr kyriakos Papadopoulos, a clinical researcher at South Texas start, in a statement Original title: FDA awarded Sanofi new drug breakthrough therapy to seize the opportunity of pharmaceutical machinery and equipment industry, please download app (Pharma, Android version)!