PHARMACEUTICAL COMPOSITIONS COMPRISING A CDK INHIBITOR

摘要

The present invention features pharmaceutical and lyophilized compositions comprising {5-[3­(4,6-Difluoro-1 H-benzoimidazol-2-yl)-1 Hindazol-5-yl]-4-methyl-pyridin-3-ylmethyl}-ethyl-amine, an inhibitor of cyclin-dependent kinases (CDKs). The pharmaceutical and lyophilized compositions are suitable for parenteral administration, wherein the composition comprises {5-[3-(4,6-Difluoro-1 H benzoimidazol-2-yl)-1 H-indazol-5-yl]-4-methyl-pyridin-3-ylmethyl}-ethyl-amine, a Solubilizing Agent, and a Stabilizing Agent as defined herein. Also disclosed are methods of making the compositions, and methods of treating cell-proliferative disorders by administration of the compositions.