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Unlabeled uses of commercial products or investigational uses not yet approved
SEMINARS IN ONCOLOGY NURSING A New Biological Approach for the Treatment of Metastatic Breast Cancer Unlabeled Uses of Commercial Products or Investigational Uses Not Yet Approved phamide/doxorubiein/vineristine/prednisone, a-interferon, and IDEC-Y2B8 radioimmunotherapy has not been approved by the FDA. Trastuzumab has been approved by the FDA for patients whose tumors overexpress the HER2 protein (1) for first-line treatment of metastatic breast cancer in combination with paclitaxel, and (2) as a single agent in patients who have received prior ehemotherapy for metastatie disease.
NOTICE ABOUT OFF-LABEL USE PRESENTATIONS HESE PROCEEDINGS may include pre-
T sentations on drugs or devices, or uses of
drugs or deviees, that have not been approved by the Food and Drug Administration (FDA) or have been approved by the FDA for speeifie uses only. The FDA has stated that it is the responsibility of the physieian to determine the FDA elearance status of each drug or deviee he or she wishes to use in elinieal praetiee. The Center for Biomedieal Continuing Education is committed to the free exchange of nursing education. Inclusion of any presentation in this program, including presentations on off-label uses, does not imply an endorsement by The Center for Biomedical Continuing Education of the uses, products, or techniques presented. For additional information about approved uses, cheek the package labeling or eonsult the Physician's Desk Reference.
Development and Clinical Overview of Trastuzumab (Herceptin), Cynthia Frankel Trastuzumab has been approved by the FDA for patients whose tumors overexpress the HER2 protein (1) for first-line treatment of metastatic breast cancer in eombination with paclitaxel, and (2) as a single agent in patients who have received prior chemotherapy for metastatic disease. Paelitaxel has been approved by the FDA for the treatment of breast cancer after failure of combination chemotherapy for metastatie disease, or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthraeyeline unless elinieally contraindicated. Cyelophosphamide is indieated as a single agent or in combination with other chemotherapy drugs for the treatment of breast cancer. Doxorubicin is indicated as a single agent or in combination with other ehemotherapy drugs for the treatment of breast cancer.
Recent Advances in Immunotherapy and Monoelonal Antibody Treatment of Cancer,
Cheng et al Rituximab has been approved by the FDA for the treatment of patients with relapsed or refraetory low-grade or follicular CD20positive B-cell non-Hodgkin's lymphoma. The combination of rituximab with cyclophos-
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NOTICE ABOUT OFF-LABEL USE PRESENTATIONS HESE PROCEEDINGS may include pre-
T sentations on drugs or devices, or uses of
drugs or deviees, that have not been approved by the Food and Drug Administration (FDA) or have been approved by the FDA for speeifie uses only. The FDA has stated that it is the responsibility of the physieian to determine the FDA elearance status of each drug or deviee he or she wishes to use in elinieal praetiee. The Center for Biomedieal Continuing Education is committed to the free exchange of nursing education. Inclusion of any presentation in this program, including presentations on off-label uses, does not imply an endorsement by The Center for Biomedical Continuing Education of the uses, products, or techniques presented. For additional information about approved uses, cheek the package labeling or eonsult the Physician's Desk Reference.
Development and Clinical Overview of Trastuzumab (Herceptin), Cynthia Frankel Trastuzumab has been approved by the FDA for patients whose tumors overexpress the HER2 protein (1) for first-line treatment of metastatic breast cancer in eombination with paclitaxel, and (2) as a single agent in patients who have received prior chemotherapy for metastatic disease. Paelitaxel has been approved by the FDA for the treatment of breast cancer after failure of combination chemotherapy for metastatie disease, or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthraeyeline unless elinieally contraindicated. Cyelophosphamide is indieated as a single agent or in combination with other chemotherapy drugs for the treatment of breast cancer. Doxorubicin is indicated as a single agent or in combination with other ehemotherapy drugs for the treatment of breast cancer.
Recent Advances in Immunotherapy and Monoelonal Antibody Treatment of Cancer,
Cheng et al Rituximab has been approved by the FDA for the treatment of patients with relapsed or refraetory low-grade or follicular CD20positive B-cell non-Hodgkin's lymphoma. The combination of rituximab with cyclophos-
38