Spectrum Pharmaceuticals submits updated BLA to the USFDA for Rolontis

Spectrum Pharmaceuticals has submitted updated BLA to the USFDA, for  Rolontis, based on two large pivotal randomized controlled studies that met all primary and secondary endpoints, seeking an indication for the treatment of neutropenia in patients receiving myelosuppressive anti-cancer drugs.

HENDERSON, Nev.–(BUSINESS WIRE)–Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biotechnology company with a primary focus in hematology and oncology, announced today that the company submitted an updated Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for ROLONTIS (eflapegrastim).

The BLA 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. 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.

“We have submitted a robust package to the FDA that incorporates strong clinical data and addresses previously communicated FDA requests relating to manufacturing processes,” said Joe Turgeon, President and CEO of Spectrum. “ROLONTIS could be the first novel G-CSF available to healthcare providers in over 15 years and, if approved, we are looking forward to competing in this multibillion-dollar market.”

In March 2019, Spectrum voluntarily withdrew the ROLONTIS BLA that it filed with the FDA in 2018. The updated BLA filed today includes additional information in the Chemistry, Manufacturing and Controls (CMC) section.