Preclinical and clinical data for tbo-filgrastim: A short-acting filgrastim.

e13555 Background: Tbo-filgrastim is a G-CSF approved in the US as a biologic under the BLA 351(a) pathway, for reducing duration of severe neutropenia (DSN) in patients with non-myeloid malignancies receiving chemotherapy (CTx) associated with a clinically significant incidence of febrile neutropenia (FN). Here, we summarize data from the development program (16 preclinical studies; 2 Phase I and 3 Phase III clinical studies). Methods: Preclinical: The PK, safety pharmacology, PD, and toxicology of tbo-filgrastim vs reference filgrastim were investigated in 3 in vitro studies and 13 animal model studies. Clinical: The PK/PD of tbo-filgrastim and filgrastim were compared in 2 Phase I studies in 200 healthy volunteers. The safety and efficacy of tbo-filgrastim were compared with filgrastim in 3 Phase III studies in 677 patients receiving CTx for breast cancer (BC), lung cancer (LC) and non-Hodgkin lymphoma (NHL). The BC study, in which DSN was the primary parameter, was placebo controlled. Results: Preclin...