FDA provides complete response letter for rolapitant IV New Drug Application for delayed nausea and vomiting- Tesaro

Tesaro announced that the U.S. FDA has issued a Complete Response Letter (CRL) 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. The 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 (API), which is also used for the rolapitant oral product.