January 12, 2017
By Alex Keown, BioSpace.com Breaking News Staff
WALTHAM, Mass. – Shares of Tesaro, Inc. continue to fall this morning after the U.S. Food and Drug Administration (FDA) denied its New Drug Application for rolapitant IV, an injectable version of its oral treatment Varubi.
In a Complete Response Letter, the FDA asked for 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 said late Wednesday. The company said it is working “expeditiously” to provide the required information to the federal agency. The FDA’s CRL did not raise questions about safety or efficacy of the medication, nor did it request any additional clinical studies, Tesaro said in its statement. Also, Tesaro said the FDA did not raise any concerns regarding the active pharmaceutical ingredient, which is also used in the oral product, Varubi. The oral Varubi was approved in 2015.
Rolapitant IV is used for the prevention of delayed nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy. Varubi is a substance P/neurokinin-1 (NK-1) receptor antagonist indicated in combination with other antiemetic agents in adults for the prevention of delayed nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy. NK-1 receptors are highly concentrated in the brain and bind neurokinin substance P, according to company data.
“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,” Mary Lynne Hedley, Tesaro’s president and chief operating officer said in a statement. “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.”
The company said the FDA raised concerns about Tesaro’s switching of drug manufacturers. Tesaro said it 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, the FDA requested and Tesaro provided in vitro data to demonstrate comparability of drug product made at the two manufacturing sites, the company said.
Tesaro is the latest company to have its momentum halted by the FDA’s concerns over manufacturing issues. Last year, Sanofi and Regeneron had hoped for approval of sarilumab, the rheumatoid arthritis drug, but the FDA objected to the drug due to certain deficiencies identified during a routine good manufacturing practice inspection of the Sanofi Le Trait facility in France where sarilumab is filled and finished.
In addition to working with the FDA on rolapitant IV, Tesaro remains focused on gaining approval for its ovarian cancer treatment, Niraparib, an oral, once-daily PARP inhibitor.
