Posted by Michael Wonder on 28 Dec 2018
Spectrum Pharmaceuticals announces submission of biologics license application to the FDA for Rolontis (eflapegrastim) as a treatment for chemotherapy-induced neutropenia
27 December 2018 - Submission based on results from two large, positive pivotal trials.
Spectrum Pharmaceuticals announced today that the company submitted a biologics license application with the U.S. FDA for Rolontis (eflapegrastim).
The application for Rolontis is supported by data from two identically designed Phase 3 clinical trials, ADVANCE and RECOVER, which evaluated the safety and efficacy of Rolontis in 643 early-stage breast cancer patients for the treatment of neutropenia due to myelosuppressive cytoxic chemotherapy. The study ADVANCE was conducted under a special protocol assessment (SPA) with the Agency. In both studies, Rolontis demonstrated the pre-specified hypothesis of non-inferiority (NI) in Duration of Severe Neutropenia (DSN) and a similar safety profile to pegfilgrastim. ROLONTIS also demonstrated non-inferiority to pegfilgrastim in the DSN across all 4 cycles (all NI p<0.0001) in both studies.
