Posted by Michael Wonder on 13 Jan 2017
Tesaro receives complete response letter for rolapitant IV from U.S. FDA
11 January 2017 - No concerns raised by FDA related to the rolapitant IV efficacy or safety profile and additional clinical studies are not required
Tesaro today announced that the U.S. FDA has issued a complete response letter regarding the rolapitant IV new drug application (NDA) for the prevention of delayed nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy.
FDA requested additional information regarding the in vitro method utilized to demonstrate comparability of drug product produced at the two proposed commercial manufacturers for rolapitant IV that were included in the NDA. Tesaro is working expeditiously to provide the requested information.
The CRL did not identify concerns related to the safety or efficacy of rolapitant IV or request additional clinical studies. No concerns were raised regarding the active pharmaceutical ingredient, which is also used for the Varubi (rolapitant) oral product.
