Claims for Patent: 7,132,554

Summary for Patent: 7,132,554

Title:	Therapeutic synergy of anti-cancer compounds
Abstract:	This invention relates to a synergistic therapeutic combination of anti-cancer compounds which comprises a) a taxane, and b) a substance that binds to the epidermal growth factor receptor (EGFR) and blocks the ability of epidermal growth factor (EGF) to intitiate receptor activities which results in tumor growth inhibition, and optionally at least one pharmaceutically acceptable carrier for simultaneous, separate or sequential use.
Inventor(s):	Rose; William C. (Pipersville, PA)
Assignee:	Bristol-Myers Squibb Company (Princeton, NJ)
Application Number:	11/079,064
Patent Claims:	1. A synergistic pharmaceutical combination of anti-cancer compounds which comprises a) an orally administered taxane compound of the formula, ##STR00004## wherein: R is ted butyl; R.sup.1 is --C(O)R.sup.Z in which R.sup.Z is (CH.sub.3).sub.3CO--; and R.sup.2 is CH.sub.3C(O)O--, and b) the epidermal growth factor receptor antibody, cetuximab, in which the active ingredients are present in each case in free form or as a pharmaceutically acceptable salt, solvate or ester. 2. The combination according to claim 1 wherein the taxane is administered orally at a synergistically thereapeutic effective dose of 8 to 320 mg/m.sup.2 p.o. every 1 to 14 days for 1 or more administrations. 3. The combination according to claim 1 wherein cetuximab is administered at a synergistically thereapeutic effective dose of 4 to 400 mg/m.sup.2. i.v. every 1 to 14 days for 1 or more administrations. 4. The combination according to claim 1 wherein the taxane is administered orally at at a synergistically thereapeutic effective dose of 8 to 320 mg/.sup.2 p.o. every 1 to 14 days for 1 or more administrations and cetuximab is administered at a synergistically thereapeutic effective dose of 4 to 400 mg/m.sup.2. i.v. every 1 to 14 days for 1 or more administrations. 5. A method for the treatment of cancer which comprises administering to a patient in need thereof a synergistically therapeutic amount of a) an orally administered taxane compound of the formula, ##STR00005## wherein: R is ted butyl; R.sup.1 is --C(O)R.sup.Z in which R.sup.Z is (CH.sub.3).sub.3--; and R.sup.2 is CH.sub.3C(O)O--, and b) the epidermal growth factor receptor antibody, cetuximab, in which the active ingredients are present in each case in free form or as a pharmaceutically acceptable salt, solvate or ester. 6. The method according to claim 5 wherein the taxane is administered orally at a synergistically thereapeutic effective dose of 8 to 320 mg/m.sup.2 p.o. every 1 to 14 days for 1 or more administrations. 7. The method according to claim 5 wherein cetuximab is administered at a synergistically thereapeutic effective dose of 4 to 400 mg/m.sup.2. i.v. every 1 to 14 days for 1 or more administrations. 8. The combination according to claim 5 wherein the taxane is administered orally at at a synergistically thereapeutic effective dose of 8 to 320 mg/m.sup.2 p.o. every 1 to 14 days for 1 or more administrations and cetuximab is administered at a synergistically thereapeutic effective dose of 4 to 400 mg/m.sup.2. i.v. every 1 to 14 days for 1 or more administrations. 9. The method according to claim 5 wherein the cancer treated is selected from colorectal cancer, breast cancer, gastric cancer, ovarian cancer, non-small cell lung cancer and cancers of the head and neck.

Details for Patent 7,132,554

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Eli Lilly And Company	ERBITUX	cetuximab	Injection	125084	02/12/2004		2024-03-16
Eli Lilly And Company	ERBITUX	cetuximab	Injection	125084	03/28/2007		2024-03-16