Tesaro receives CRL for rolapitant IV from FDA

No concerns raised by FDA related to the rolapitant IV efficacy or safety profile and additional clinical studies are not required.

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 API, which is also used for the Varubi (rolapitant) 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.

"Chemotherapy-induced nausea and vomiting remains a significant unmet need, with more than half of patients treated with emetogenic chemotherapy experiencing this debilitating side effect," said Mary Lynne Hedley, President and COO of Tesaro. "Tesaro is committed to bringing this new intravenous formulation of rolapitant to physicians and patients to enable additional flexibility and choice of antiemetic regimens, and we plan to address FDA's questions expeditiously and complete this application, which we expect to enable approval in the first half of 2017."