Claims for Patent: 9,474,754

Summary for Patent: 9,474,754

Title:	Pharmaceutical combinations comprising a B-RAF inhibitor, and EGFR inhibitor and optionally a PI3K-.alpha. inhibitor
Abstract:	A pharmaceutical combination comprising (a) a B-Raf inhibitor, (b) a EGFR inhibitor and, optionally, (c) a PI3K inhibitor; the uses of such combination in the treatment of proliferative diseases; and methods of treating a subject suffering from a proliferative disease comprising administering a therapeutically effective amount of such combination.
Inventor(s):	Caponigro; Giordano (Foxborough, MA), Stuart; Darrin (Pleasant Hill, CA), Moutouh-De Parseval; Laure (Basel, CH)
Assignee:	NOVARTIS AG (Basel, CH)
Application Number:	14/419,256
Patent Claims:	1. A pharmaceutical combination comprising: (a) a B-Raf inhibitor of the formula ##STR00012## or a pharmaceutically acceptable salt thereof, and (b) an EGFR inhibitor, wherein the EGFR inhibitor is erlotinib or cetuximab, and, optionally, (c) a PI3K-.alpha. inhibitor, wherein the PI3K-.alpha. inhibitor is Compound B ##STR00013## wherein the B-Raf inhibitor, the EGFR inhibitor, and Compound B are each formulated as single formulations for simultaneous, separate or sequential administration. 2. The pharmaceutical combination of claim 1 wherein the EGFR inhibitor is erlotinib. 3. The pharmaceutical combination of claim 1 wherein the EGFR inhibitor is cetuximab. 4. A method for treating a proliferative disease in a human patient wherein the proliferative disease is characterized by a B-Raf mutation, comprising the simultaneous, separate or sequential administration of a therapeutically effective amount of (a) a B-Raf inhibitor of the formula ##STR00014## or a pharmaceutically acceptable salt thereof, and (b) an EGFR inhibitor, wherein the EGFR inhibitor is erlotinib or cetuximab, and, optionally, (c) a PI3K-.alpha. inhibitor, wherein the PI3K-.alpha. inhibitor is Compound B ##STR00015## wherein the B-Raf inhibitor, the EGFR inhibitor, and Compound B are each formulated as single formulations. 5. The method according to claim 4 wherein the B-Raf mutation is a V600 mutation. 6. The method according to claim 4, wherein the proliferative disease is colorectal cancer. 7. The method according to claim 4, wherein the B-Raf inhibitor is administered orally in an amount of 10 mg per day to 1000 mg per day. 8. The method according to claim 4, wherein the B-Raf inhibitor is administered orally in an amount of 50 mg per day to 450 mg per day. 9. The method according to claim 7, wherein the B-Raf inhibitor is administered once or twice per day. 10. The method according to claim 4, wherein the EGFR inhibitor is cetuximab, wherein the cetuximab is administered as an intravenous infusion in an amount of 200 mg/m.sup.2 to 400 mg/m.sup.2 followed by weekly doses of from 125 mg/m.sup.2 to 250 mg/m.sup.2. 11. The method according to claim 4, wherein Compound B is administered orally in an amount of 30 mg per day to 450 mg per day. 12. The method according to claim 11, wherein Compound B is administered once or twice per day. 13. The method according to claim 4, wherein the B-Raf inhibitor and cetuximab are administered separately. 14. The method according to claim 4, wherein the B-Raf inhibitor and Compound B are administered simultaneously. 15. The method according to claim 5, wherein the V600 mutation is a V600E mutation or a V600K mutation. 16. The method according to claim 6, wherein the colorectal cancer is characterized by a V600E mutation or a V600K mutation.

Details for Patent 9,474,754

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Eli Lilly And Company	ERBITUX	cetuximab	Injection	125084	02/12/2004		2039-02-26
Eli Lilly And Company	ERBITUX	cetuximab	Injection	125084	03/28/2007		2039-02-26