FDA Rejects Tesaro’s Rolapitant IV

The FDA has issued a complete response letter regarding the NDA for rolapitant IV, developed by Tesaro for the prevention of delayed nausea and vomiting associated with initial and repeat courses of chemotherapy.

The FDA has requested additional information regarding the in vitro method used to demonstrate comparability of the drug product produced at the two proposed commercial manufacturers for rolapitant IV.

The CRL did not identify concerns related to the safety or efficacy of rolapitant IV, or request additional clinical studies.