Sanofi: study results on cemiplimab published in NEJM
(CercleFinance.com) - Sanofi has announced the publication, in the New England Journal of Medicine (NEJM) of the results of two pivotal clinical trials dedicated to cemiplimab in the treatment of advanced cutaneous squamous carcinoma (CEC), the deadliest form of non-melanoma skin cancer.
These results were submitted to Cemiplimab applications for approval in CEC (advanced stage), which were accepted by the US FDA, which will give it a priority review, as well as by the European Medicines Agency (EMA).
The FDA is set to make its decision on 28 October, with the EMA evaluation process set to be complete by the end of the first half of 2019. Requests for approval in other countries are also planned and should also be presented this year.
Copyright (c) 2018 CercleFinance.com. All rights reserved.
These results were submitted to Cemiplimab applications for approval in CEC (advanced stage), which were accepted by the US FDA, which will give it a priority review, as well as by the European Medicines Agency (EMA).
The FDA is set to make its decision on 28 October, with the EMA evaluation process set to be complete by the end of the first half of 2019. Requests for approval in other countries are also planned and should also be presented this year.
Copyright (c) 2018 CercleFinance.com. All rights reserved.