Posted by Michael Wonder on 27 Oct 2019
Spectrum Pharmaceuticals announces submission to the U.S. FDA of updated biologics license application for Rolontis
24 October 2019 - Rolontis filing is based on two large pivotal randomised controlled studies that met all primary and secondary endpoints.
Spectrum Pharmaceuticals announced today that the company submitted an updated biologics license application to 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 chemotherapy.
