Claims for Patent: 7,449,184

Summary for Patent: 7,449,184

Title:	Fixed dosing of HER antibodies
Abstract:	The present invention concerns fixed dosing of HER antibodies, such as Pertuzumab.
Inventor(s):	Allison; David E. (San Mateo, CA), Bruno; Rene (Marseilles, FR), Lu; Jian-Feng (Foster City, CA), Ng; Chee M. (San Mateo, CA)
Assignee:	Genentech, Inc. (South San Francisco, CA)
Application Number:	11/154,091
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 7,449,184
Patent Claims:	1. A method for treating HER2 expressing cancer comprising administering one or more fixed dose(s) of HER2 antibody to a human patient in an amount effective to treat the cancer, wherein the fixed dose is selected from the group consisting of approximately 420 mg, approximately 525 mg, approximately 840 mg, and approximately 1050 mg of the HER2 antibody, wherein the HER2 antibody comprises the variable light and variable heavy amino acid sequences in SEQ ID Nos. 3 and 4, respectively. 2. The method of claim 1 wherein the HER2 antibody is pertuzumab. 3. The method of claim 1 wherein the fixed dose is 420 mg of the HER2 antibody. 4. The method of claim 1 wherein the fixed dose is 840 mg of the HER2 antibody. 5. The method of claim 1 wherein the fixed dose is 1050 mg of the HER2 antibody. 6. The method of claim 1 wherein the fixed dose is 525 mg of the HER2 antibody. 7. The method of claim 1 wherein a fixed dose of the HER2 antibody is administered to the patient approximately every week, approximately every 2 weeks, approximately every 3 weeks, or approximately every 4 weeks. 8. The method of claim 7 wherein a fixed dose of the HER2 antibody is administered to the patient approximately every 3 weeks. 9. The method of claim 1 comprising administering a loading dose of approximately 840 mg of the HER2 antibody followed by one or more maintenance doses of approximately 420 mg of the HER2 antibody. 10. The method of claim 9 wherein the maintenance doses are administered approximately every 3 weeks. 11. The method of claim 1 comprising administering a loading dose of approximately 1050 mg of the HER2 antibody followed by one or more maintenance doses of approximately 525 mg of the HER2 antibody. 12. The method of claim 11 wherein the maintenance doses are administered approximately every 3 weeks. 13. The method of claim 1 wherein the HER2 antibody is a naked antibody. 14. The method of claim 1 wherein the HER2 antibody is an intact antibody. 15. The method of claim 1 wherein the HER2 antibody is an antibody fragment comprising an antigen binding region. 16. The method of claim 1 wherein the HER2 antibody is a humanized or human IgG1antibody. 17. The method of claim 1 wherein the cancer displays HER2 expression, amplification, or activation. 18. The method of claim 1 wherein the cancer is ovarian, peritoneal, or fallopian tube cancer. 19. The method of claim 1 wherein the cancer is metastatic breast cancer (MBC). 20. The method of claim 1 wherein the cancer is non-small cell lung cancer (NSCLC). 21. The method of claim 1 wherein the cancer is prostate cancer. 22. The method of claim 1 wherein the cancer is colorectal cancer. 23. The method of claim 1 comprising administering a second therapeutic agent to the patient. 24. The method of claim 23 wherein the second therapeutic agent is selected from the group consisting of chemotherapeutic agent, different HER2 antibody, antibody directed against a different tumor associated antigen, anti-hormonal compound, cardioprotectant, cytokine, EGFR-targeted drug, anti-angiogenic agent, tyrosine kinase inhibitor, COX inhibitor, non-steroidal anti-inflammatory drug, farnesyl transferase inhibitor, antibody that binds oncofetal protein CA 125, HER2 vaccine, another HER targeting therapy, Raf or ras inhibitor, doxorubicin HCL liposome injection, topotecan, taxane, dual tyrosine kinase inhibitor, TLK286, EMD-7200, a medicament that treats nausea, a medicament that prevents or treats skin rash or standard acne therapy, a body temperature-reducing medicament, and a hematopoietic growth factor. 25. The method of claim 24 wherein the second therapeutic agent is a chemotherapeutic agent. 26. The method of claim 25 wherein the chemotherapeutic agent is an antimetabolite chemotherapeutic agent. 27. The method of claim 26 wherein the antimetabolite chemotherapeutic agent is gemcitabine. 28. The method of claim 23 wherein the second therapeutic agent is trastuzumab, erlotinib HCL, or bevacizumab. 29. A method of treating HER2 expressing cancer in a human patient comprising administering at least one fixed dose of pertuzumab to the patient, wherein the fixed dose is selected from the group consisting of approximately 420 mg, approximately 525 mg, approximately 840 mg, and approximately 1050 mg of pertuzumab. 30. The method of claim 29 wherein a fixed dose of pertuzumab is administered to the patient approximately every 3 weeks. 31. The method of claim 29 wherein the cancer is selected from the group consisting of ovarian cancer, peritoneal cancer, fallopian tube cancer, metastatic breast cancer (MBC), non-small cell lung cancer (NSCLC), prostate cancer, and colorectal cancer. 32. The method of claim 29 wherein the fixed dose is selected from the group consisting of 420 mg, 525 mg, 840 mg, and 1050 mg of pertuzumab.

Details for Patent 7,449,184

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Genentech, Inc.	HERCEPTIN	trastuzumab	For Injection	103792	09/25/1998		2025-01-21
Genentech, Inc.	HERCEPTIN	trastuzumab	For Injection	103792	02/10/2017		2025-01-21
Genentech, Inc.	AVASTIN	bevacizumab	Injection	125085	02/26/2004		2025-01-21
Genentech, Inc.	PERJETA	pertuzumab	Injection	125409	06/08/2012		2025-01-21
Genentech, Inc.	HERCEPTIN HYLECTA	trastuzumab and hyaluronidase-oysk	Injection	761106	02/28/2019		2025-01-21