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Last Updated: April 25, 2024

Claims for Patent: 8,591,897

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Summary for Patent: 8,591,897

Title:	Anti-ERBB2 antibody adjuvant therapy
Abstract:	The present application describes adjuvant therapy of nonmetastatic breast cancer using HERCEPTIN.RTM..
Inventor(s):	Bryant; John L. (Allison Road, PA)
Assignee:	Genentech, Inc. (South San Francisco, CA)
Application Number:	11/400,638
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,591,897
Patent Claims:	1. A method of adjuvant therapy comprising administering to a human subject with nonmetastatic HER2 positive breast cancer, following definitive surgery, anthracycline/cyclophosphamide (AC) based chemotherapy, followed by sequential administration of a taxoid and trastuzumab or an antibody that blocks binding of trastuzumab to HER2. 2. The method of claim 1, wherein the taxoid is paclitaxel or docetaxel. 3. The method of claim 2, wherein trastuzumab is administered. 4. The method of claim 3, wherein trastuzumab is administered at an initial dose or 4 mg/kg, followed by subsequent weekly doses of 2 mg/kg. 5. The method of claim 1, wherein the subject has a high risk of cancer recurrence. 6. The method of claim 5 wherein the subject is less than about 50 years old. 7. The method of claim 5 wherein the subject had a tumor greater than 2 centimeters in diameter. 8. The method of claim 5 wherein the cancer is lymph node-positive. 9. The method of claim 8 wherein the subject had 4-9 involved lymph nodes. 10. The method of claim 8 wherein the subject had 10 or more involved lymph nodes. 11. The method of claim 5 wherein the subject's cancer was estrogen receptor (ER) negative. 12. The method of claim 5 wherein the subject's cancer was progesterone receptor (PG) negative. 13. The method of claim 1, wherein the antibody is an intact, naked antibody.

Details for Patent 8,591,897

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Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Genentech, Inc.	HERCEPTIN	trastuzumab	For Injection	103792	09/25/1998	⤷ Try a Trial	2025-05-13
Genentech, Inc.	HERCEPTIN	trastuzumab	For Injection	103792	02/10/2017	⤷ Try a Trial	2025-05-13
Genentech, Inc.	HERCEPTIN HYLECTA	trastuzumab and hyaluronidase-oysk	Injection	761106	02/28/2019	⤷ Try a Trial	2025-05-13
>Applicant	>Tradename	>Biologic Ingredient	>Dosage Form	>BLA	>Approval Date	>Patent No.	>Expiredate

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