The complete response letter Tesaro Inc. received from US FDA this week likely won’t create major delays for approval of intravenous rolapitant, but it does continue a recent trend of increasing CRLs pertaining to chemistry, manufacturing and controls-related issues.
The Waltham, MA-based biotech revealed the complete response Jan. 11, which was the FDA action date for its NDA for IV rolapitant, approved in September 2015 as an oral drug named Varubi for prevention of delayed nausea and vomiting associated with emetogenic cancer chemotherapy. (Also see "Tesaro's Varubi Wins FDA Approval; Shares Up" - Scrip, 3 September, 2015.) On a Jan