Nova Patents
EP2116262A3

Gene detection assay for improving the likelihood of an effective response to an ErbB antagonist cancer therapy

Abstract

The invention provides a method for more effective treatment of patients susceptible to or diagnosed with tumors overexpressing ErbB, as determined by a gene amplification assay, with an ErbB antagonist. Such method comprises administering a cancer-treating dose of the ErbB antagonist, preferably in addition to chemotherapeutic agents, to a subject in whose tumor cells ErbB has been found to be amplified e.g., by fluorescent in situ hybridization. ErbB antagonists described include an anti-HER2 antibody. Pharmaceutical packaging for providing the components for such treatment is also provided.

Term

Term ended

Projected expiry passed 18 May 2021, 5.4 years ago.

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Citations
DocumentRelationOfficeCategoryCited duringRelevant claims
WO9931140A1CitesWorld Intellectual Property Organization (WIPO)XSearch report1-15
ANONYMOUS: "FDA Clinical Review of BLA 98-0369 Herceptin Trastuzumab (rhuMAb HER2)", 1998, pages 1 - 49, XP002614455, Retrieved from the Internet <URL:http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm091364.pdf> [retrieved on 20101215]Non-patent––Search report–
ANONYMOUS: "FDA Clinical Review of BLA 98-0369 Herceptin Trastuzumab (rhuMAb HER2)", 1998, pages 50 - 99, XP002614456, Retrieved from the Internet <URL:http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm091366.pdf> [retrieved on 20101215]Non-patent––Search report–
ANONYMOUS: "Product Approval Information - Licensing Action", 13 April 2000 (2000-04-13), XP002614457Non-patent––Search report–
LEWIS G D ET AL: "Differential responses of human tumor cell lines to anti-p 185HER2 monoclonal antibodies", CANCER IMMUNOLOGY AND IMMUNOTHERAPY, SPRINGER-VERLAG, BERLIN, DE, vol. 37, no. 4, 1 September 1993 (1993-09-01), pages 255 - 263, XP002961547, ISSN: 0340-7004, DOI: 10.1007/BF01518520Non-patent––Search report–
STANCOVSKI I ET AL: "Mechanistic aspects of the opposing effects of monoclonal antibodies to the ERBB2 receptor on tumor growth", PROCEEDINGS OF THE NATIONAL ACADEMY OF SCIENCES OF THE UNITED STATES (PNAS), NATIONAL ACADEMY OF SCIENCE, US, vol. 88, no. 19, 1 October 1991 (1991-10-01), pages 8691 - 8695, XP002994671, ISSN: 0027-8424, DOI: 10.1073/PNAS.88.19.8691Non-patent––Search report–
ROSS JEFFREY ET AL: "THE HER-2/NEU ONCOGENE IN BREAST CANCER: PROGNOSTIC FACTOR, PREDICTIVE FACTOR, AND TARGET FOR THERAPY.", STEM CELLS (MIAMISBURG), vol. 16, no. 6, 1998, pages 413 - 428, XP002178259, ISSN: 1066-5099Non-patent––Search report–
JACOBS T W ET AL: "Comparison of fluorescence in situ hybridization and immunohistochemistry for the evaluation of HER-2/neu in breast cancer.", JOURNAL OF CLINICAL ONCOLOGY : OFFICIAL JOURNAL OF THE AMERICAN SOCIETY OF CLINICAL ONCOLOGY JUL 1999 LNKD- PUBMED:10561247, vol. 17, no. 7, July 1999 (1999-07-01), pages 1974 - 1982, XP002614620, ISSN: 0732-183XNon-patent––Search report–
SNEIGE N ET AL: "HER-2/neu gene amplification (HER-2 amp) compared with HER-2/neu protein overexpression (HER-2 exp) and interobserver reproducibility in invasive breast cancer", LABORATORY INVESTIGATION, vol. 80, no. 1, January 2000 (2000-01-01), & 2000 ANNUAL MEETING UNITED STATES AND CANADIAN ACADEMY OF PATHOLOGY.; NEW ORLEANS, LOUISIANA, USA; MARCH 25-31, 2000, pages 47A, XP002614621, ISSN: 0023-6837Non-patent––Search report–
OHNISHI Y ET AL: "Prolonged survival of mice with human gastric cancer treated with an anti-c-ErbB-2 monoclonal antibody", BRITISH JOURNAL OF CANCER, NATURE PUBLISHING GROUP, LONDON, GB, vol. 71, no. 5, 1 May 1995 (1995-05-01), pages 969 - 973, XP009122084, ISSN: 0007-0920Non-patent––Search report–
WANG S ET AL: "LABORATORY ASSESSMENT OF THE STATUS OF HER-2/NEU PROTEIN AND ONCOGENE IN BREAST CANCER SPECIMENS: COMPARISON OF IMMUNOHISTOCHEMISTRY ASSAY WITH FLUORESCENCE IN SITU HYBRIDISATION ASSAYS.", JOURNAL OF CLINICAL PATHOLOGY (LONDON), vol. 53, no. 5, May 2000 (2000-05-01), pages 374 - 381, XP001016275, ISSN: 0021-9746Non-patent––Search report–
PERSONS DIANE L ET AL: "FLUORESCENCE IN SITU HYBRIDIZATION (FISH) FOR DETECTION OF HER-2/NEU AMPLIFICATION IN BREAST CANCER: A MULTICENTER PORTABILITY STUDY.", ANNALS OF CLINICAL AND LABORATORY SCIENCE, vol. 30, no. 1, January 2000 (2000-01-01), pages 41 - 48, XP001016262, ISSN: 0091-7370Non-patent––Search report–
DRESSLER L ET AL: "Amplification of ErbB2 By Fluorescent In Situ Hybridization ( FISH ): An Alternate Method to Predict Outcome Following Dose-Escalated CAF in Stage II, Node Positive Breast Cancer Patients. A Cancer and Leukemia Group B (CALGB) Study (Meeting abstract).", PROC ANNU MEET AM SOC CLIN ONCOL, (1999). VOL. 18, PP. A281., 1999, Cancer and Leukemia Group B, Chicago, IL. U of North Carolina, Chapel Hill, NC and U of Kansas Medical Center, KS., XP001016343Non-patent––Search report–
CLARK G M ET AL: "Follow-up study of HER-2/neu amplification in primary breast cancer.", CANCER RESEARCH 1 FEB 1991 LNKD- PUBMED:1988136, vol. 51, no. 3, 1 February 1991 (1991-02-01), pages 944 - 948, XP002614622, ISSN: 0008-5472Non-patent––Search report–
TETU ET AL: "Prevalence and Clinical Significance of Her-2/neu, p53 and Rb Expression in Primary Superficial Bladder Cancer", JOURNAL OF UROLOGY, LIPPINCOTT WILLIAMS & WILKINS, BALTIMORE, MD, US, vol. 155, no. 5, 1 May 1996 (1996-05-01), pages 1784 - 1788, XP005576349, ISSN: 0022-5347, DOI: 10.1016/S0022-5347(01)66198-6Non-patent––Search report–
MITCHELL M S ET AL: "The role of immunohistochemistry and fluorescence in situ hybridization for HER2/neu in assessing the prognosis of breast cancer.", SEMINARS IN ONCOLOGY AUG 1999 LNKD- PUBMED:10482202, vol. 26, no. 4 Suppl 12, August 1999 (1999-08-01), pages 108 - 116, XP002614623, ISSN: 0093-7754Non-patent––Search report–
CARLSON ROBERT W ET AL: "HER2 TESTING IN BREAST CANCER: NCCN TASK FORCE REPORT AND RECOMMENDATIONS", JNCCN. JOURNAL OF THE NATIONAL COMPREHENSIVE CANCER NETWORK, JONES AND BARTLETT PUBLISHERS, SUDBURY, MA, US, 1 July 2006 (2006-07-01), pages S1 - S23, XP008077420, ISSN: 1540-1405Non-patent––Search report–
WOLFF ANTONIO C ET AL: "AMERICAN SOCIETY OF CLINICAL ONCOLOGY/COLLEGE OF AMERICAN PATHOLOGISTS GUIDELINE RECOMMENDATIONS FOR HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 TESTING IN BREAST CANCER", ARCHIVES OF PATHOLOGY & LABORATORY MEDICINE, COLLEGE OF AMERICAN PATHOLOGISTS, US, vol. 131, no. 1, 1 January 2007 (2007-01-01), pages 18 - 43, XP008077476, ISSN: 0003-9985Non-patent––Search report–