Novartis AG
CYCLODEXTRIN-BASED FORMULATION OF A BCL-2 INHIBITOR

Abstract:

The invention relates to a pharmaceutical composition comprising 5-(5-chloro-2-{[(3S)-3-(morpholin-4-ylmethyl)-3,4-dihydroisoquinolin-2(1H- )-yl]carbonyl} phenyl)-N-(5-cyano-1,2-dimethyl-1H-pyrrol-3-yl)-N-(4-hydroxyphenyl)-1,2-d- imethyl-1H-pyrrole-3-carboxamide, referred to herein as `Compound A`, or a pharmaceutically acceptable salt thereof, and a cyclodextrin. More specifically, the invention relates to a solid pharmaceutical composition comprising Compound A and a cyclodextrin, and a pharmaceutical composition for parenteral administration prepared by dissolving this solid pharmaceutical composition. Furthermore, the invention relates to the use of such compositions for the treatment of cancer.