CA2942072C — Pharmaceutical compositions and use of (s)-1-(2-chlorophenyl)-2-((3,3-difluorocyclobutyl)amino)-2-oxoethyl)-1-( 4-cyanopyridin-2-yl)-n-( 5-fluoropyridin-3-yl)-5-oxopyrrolidine-2-carboxamide

USPTO Abstract

Provided are pharmaceutical compositions for oral administration including (a) a solid dispersion comprising between 25-75% w/w of (S)-N4S)-1-(2-chloropheny1)-243,3-difluorocyclobutyl)amino)-2-oxoethyl)- 1 -(4-cyanopyri din-2-y1)-N-(5 -fluoropyri din-3 -y1)-5 -oxopyrrolidine-2-carboxamide (Compound 1), or a pharmaceutically acceptable salt thereof and one or more polymers selected from the group consisting of HPMCAS (hydroxypropylmethylcellulose acetate succinate) and HIPMC (hydroxypropylmethylcellulose); and optionally (b) one or more pharmaceutically acceptable carrier(s), and methods of using same for treatment of advanced hematologic malignancy characterized by the presence of a mutant allele of IDH1 . Also provided are a crystalline Form 1 of (S)-N-((S)-1-(2-chloropheny1)-243,3-difluorocyclobutypamino)-2-oxoethyl)- 1 -(4-cyanopyri din-2-y1)-N-(5 -fluoropyri din-3 -y1)-5 -oxopyrrolidine-2-carboxamide (Compound 1) and a crystalline Form 2 of (S)-N-((S)-1-(2-chloropheny1)-2-((3 , 3 -di fluorocy cl obutyl)ami no)-2 -oxoethyl)- 1 -(4-cy anopyri di n-2-y1)-N-(5 -fluoropyri din-3 -y1)-5 -oxopyrroli dine-2-carb oxami de (Compound 1), and pharmaceutical compositions including same.