Spectrum Pharmaceuticals re submits BLA to the FDA for Rolontis for the treatment of neutropenia due to myelosuppressive chemotherapy.

Spectrum Pharmaceuticals, Inc. has announced that the company submitted an updated Biologics License Application (BLA) to the FDA for Rolontis (eflapegrastim). The BLA for Rolontis is supported by data from two identically designed Phase III 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. rolontis could be the first novel g-csf available to healthcare providers in over 15 years.>

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