Claims for Patent: 10,799,490

Summary for Patent: 10,799,490

Title:	Pharmaceutical compositions of therapeutically active compounds
Abstract:	Provided are compounds and pharmaceutical compositions useful for treating cancer and methods of treating cancer comprising administering to a subject in need thereof a compound or pharmaceutical composition described herein.
Inventor(s):	Gu; Chong-Hui (Waban, MA)
Assignee:	Agios Pharmaceuticals, Inc. (Cambridge, MA)
Application Number:	16/460,111
Patent Claims:	1. A pharmaceutical composition for oral administration comprising (a) a solid dispersion comprising between 25-75% w/w of (S)--N--((S)-1-(2-chlorophenyl)-2-((3,3-difluorocyclobutyl)amino)-2-oxoet- hyl)-1-(4-cyanopyridin-2-yl)-N-(5-fluoropyridin-3-yl)-5-oxopyrrolidine-2-c- arboxamide (Compound 1) or a pharmaceutically acceptable salt thereof, and a cellulosic polymer and optionally (b) one or more pharmaceutically acceptable carrier(s). 2. The pharmaceutical composition of claim 1 wherein the polymer is selected from selected from hydroxypropylmethylcelulose acetate succinate (HPMCAS) and hydroxypropylmethylcellulose (HPMC). 3. The pharmaceutical composition of claim 1 wherein the solid dispersion is a spray-dried dispersion. 4. The pharmaceutical composition of claim 1 wherein the solid dispersion comprises between about 30 and 70% w/w Compound 1. 5. The pharmaceutical composition of claim 4 wherein the solid dispersion comprises between about 40 and 60% compound 1. 6. The pharmaceutical composition of claim 5 wherein the solid dispersion comprises about 50% w/w Compound 1. 7. A pharmaceutical composition for oral administration comprising (a) a solid dispersion comprising about 50% w/w of (S)--N--((S)-1-(2-chlorophenyl)-2-((3,3-difluorocyclobutyl)amino)-2-oxoet- hyl)-1-(4-cyanopyridin-2-yl)-N-(5-fluoropyridin-3-yl)-5-oxopyrrolidine-2-c- arboxamide (Compound 1) or a pharmaceutically acceptable salt thereof, and hydroxypropylmethylcelulose acetate succinate (HPMCAS) and optionally (b) one or more pharmaceutically acceptable carrier(s). 8. A method of treating acute myelogenous leukemia (AML) in a subject, characterized by the presence of a mutant allele of IDH1, the method comprising administering to the subject in need thereof a pharmaceutical composition comprising (a) a solid dispersion comprising between 25-75% w/w 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-oxopyrrolid- ine-2-carboxamide (Compound 1) or a pharmaceutically acceptable salt thereof, and a cellulosic polymer selected from hydroxypropylmethylcelulose acetate succinate (HPMCAS) and hydroxypropylmethylcellulose (HPMC) and optionally (b) one or more pharmaceutically acceptable carrier(s). 9. A method of treating acute myelogenous leukemia (AML) in a subject, characterized by the presence of a mutant allele of IDH1, the method comprising administering to the subject in need thereof a pharmaceutical composition comprising (a) a solid dispersion comprising about 50% w/w of (S)--N--((S)-1-(2-chlorophenyl)-2-((3,3-difluorocyclobutyl)amino)-2-oxoet- hyl)-1-(4-cyanopyridin-2-yl)-N-(5-fluoropyridin-3-yl)-5-oxopyrrolidine-2-c- arboxamide (Compound 1) or a pharmaceutically acceptable salt thereof, and hydroxypropylmethylcelulose acetate succinate (HPMCAS) and optionally (b) one or more pharmaceutically acceptable carrier(s). 10. The method of claim 9, wherein the mutant IDH1 has an R132X mutation. 11. The method of claim 10, wherein the R132X mutation is selected from R132H, R132C, R132L, R132V, R132S and R132G. 12. The method of claim 11, wherein the R132X mutation is R132H or R132C.