TESARO receives CRL from FDA for rolapitant IV NDA
TESARO announced that the FDA has issued a Complete Response Letter, or CRL, regarding the rolapitant IV New Drug Application, or 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 Varub oral product. TESARO identified potential deficiencies at the original contract manufacturer for rolapitant IV drug product, secured a second drug product supplier and included data from this manufacturer in the NDA. During the NDA review, FDA requested and TESARO provided in vitro data to demonstrate comparability of drug product made at the two manufacturing sites.