CA2942072A1 — 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)-N-((S)-l-(2-chlorophenyl)-2-((3,3-difluorocyclobutyl )amino )-2-oxoethyl )-1-( 4-cyanopyridin-2-yl )-N-( 5-fluoropyridin-3-yl )-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 HPMC (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 IDHI. Also provided are a crystalline Form 1 of (S)-N-((S)-l-(2-chlorophenyl)-2-((3,3-difluorocyclobutyl )amino )-2-oxoethyl )-1-( 4-cyanopyridin-2-yl )-N-( 5-fluoropyridin-3-yl )-5-oxopyrrolidine-2-carboxamide (Compound 1) and a crystalline Form 2 of (S)-N-((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 (Compound 1), and pharmaceutical compositions including same.