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Last Updated: September 18, 2020

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Claims for Patent: 9,474,754

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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.

Summary for Patent:   Start Trial

PCT Information
PCT FiledAugust 05, 2013PCT Application Number:PCT/US2013/053619
PCT Publication Date:February 13, 2014PCT Publication Number:WO2014/025688

Details for Patent 9,474,754

Applicant Tradename Biologic Ingredient Dosage Form BLA Number Approval Date Patent No. Assignee Estimated Patent Expiration Status Orphan Source
Imclone ERBITUX cetuximab VIAL; INTRAVENOUS 125084 001 2004-06-18   Start Trial NOVARTIS AG (Basel, CH) 2039-02-26 RX Orphan search
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Number >Approval Date >Patent No. >Assignee >Estimated Patent Expiration >Status >Orphan >Source

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