IV rolapitant regulatory update

FDA issued a complete response letter to Tesaro for an NDA for IV rolapitant to prevent chemotherapy-induced nausea and vomiting (CINV). At FDA's request during the NDA review, Tesaro provided in vitro data to demonstrate comparability between drug product made by the 2 manufacturers included in the submission. The company had secured the second manufacturer after identifying “potential deficiencies” at its originally contracted supplier. According to Tesaro, FDA's letter requested additional data on the method used to show that comparability. The agency did not identify concerns related to the product’s safety, efficacy or API. Tesaro said it plans to answer FDA’s request in time for the agency to make an approval decision this half...