Spectrum Given ‘Complete Response’ on Rolontis

FDA has issued Spectrum Pharmaceuticals a complete response letter on its BLA for Rolontis (eflapegrastim), citing deficiencies related to manufacturing and stating that a reinspection will be necessary to complete its review. The company is seeking an indication for treating neutropenia in patients receiving myelosuppressive anti-cancer drugs. Spectrum says it will request a meeing with FDA to obtain further clarification.

Rolontis is described as a novel, long-acting granulocyte colony-stimulating factor. The submission is supported by data from two identically designed Phase 3 clinical trials, ADVANCE and RECOVER, which evaluated the therapy’s safety and efficacy in 643 early-stage breast cancer patients for treating neutropenia, the company says. In both studies, Rolontis demonstrated non-inferiority in “duration of severe neutropenia (DSN) and a similar safety profile to pegfilgrastim” (Amgen’s Neulasta), it says.