Claims for Patent: 9,677,139

Summary for Patent: 9,677,139

Title:	Genetic markers indicative of a cancer patient response to trastuzumab (herceptin)
Abstract:	The invention relates to the fields of therapeutics and identifying candidates for therapy, in particular to a method of identifying candidates for trastuzumab (Herceptin.RTM.) therapy in a patient presenting with breast cancer based on the presence or absence of specific genetic markers in a tumor sample from said patient.
Inventor(s):	Hicks; James (Huntington, NY), Krasnitz; Alexander (Huntington, NY)
Assignee:	COLD SPRING HARBOR LABORATORY (Cold Spring Harbor, NY)
Application Number:	13/491,359
Patent Claims:	1. A method of treating a human subject afflicted with a cancer that is determined to be responsive to trastuzumab therapy, comprising a) obtaining a biological sample that comprises cancer cells of the subject; b) determining whether a copy number of a human chromosome region beginning at 4q169.81 and ending at 4q185.239 as defined by reference to the freeze HG18 reference genome (SEQ ID NO:1) in the cancer cells is amplified, wherein determining the copy number is performed by contacting DNA extracted from the cancer cells with probes or primers so as to amplify the DNA, and determining if the copy number at region corresponding to reference region 4q169.81-q185.239 (SEQ ID NO:1) is amplified in the cancer cells compared to the copy number of region 4q169.81-q185.239 (SEQ ID NO:1) in a diploid reference; c) diagnosing the human subject to be afflicted with a cancer that is responsive to trastuzumab therapy if the human chromosome region corresponding to reference region 4q169.81-q185.239 (SEQ ID NO:1) in the cancer cells is amplified; and d) administering to the human subject diagnosed to be afflicted with a cancer that is responsive to trastuzumab therapy an amount of trastuzumab effective to treat the human subject. 2. The method of claim 1, wherein the subject is afflicted with a cancer, wherein the cells of the cancer overexpress HER2. 3. The method claim 1, wherein trastuzumab therapy is administered as a monotherapy. 4. The method of claim 1, wherein trastuzumab therapy is administered as an adjuvant therapy.

Details for Patent 9,677,139

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Genentech, Inc.	HERCEPTIN	trastuzumab	For Injection	103792	09/25/1998		2029-12-11
Genentech, Inc.	HERCEPTIN	trastuzumab	For Injection	103792	02/10/2017		2029-12-11
Genentech, Inc.	HERCEPTIN HYLECTA	trastuzumab and hyaluronidase-oysk	Injection	761106	02/28/2019		2029-12-11