| 7/15/03 | Purinethol | 6-mercaptopurine | tablet | Acute lymphatic (lymphoblastic, lymphocytic) leukemia label update for pharmacogenetic screening & multinational studies in pediatric oncology | Teva Pharmaceuticals, FDA | Link to documents | ||||
| 74th Meeting | 3/12/03 | Subpart H (Accelerated Approval)- Phase IV commitments | FDA | CBER/CDER | Yes | Link to documents | ||||
| 3/3/03 | Pediatric oncology- Labeling of oncology products for pediatric patients | FDA | CBER/CDER | Link to documents | ||||||
| 73rd Meeting | 12/18/02 | 020498 /012 | Casodex | bicalutamide | Prostate cancer- adjuvant therapy or localized non-metastatic prostate cancer for non-curative therapy | Astra Zeneca | CDER | Link to documents | ||
| 73rd Meeting | 12/17/02 | 125011 | Bexxar | Iodine131-Tositumomab | injection | Lymphoma-relapsed or refractory low-grade, follicular or transformed low-grade, B-cell non-Hodgkin's lymphoma (NHL) | Corixa | CBER | Yes | Link to documents |
| 10/17/02 | Pediatric oncology- Timing of the initiation of pediatric oncology clinical studies in a drug development program | FDA | CBER/CDER | Link to documents | ||||||
| 72nd Meeting | 9/24/02 | 021399 /000 | Iressa | gefitinib | tablet | Lung Cancer- locally advanced or metastatic non-small cell lung cancer following platinum based chemotherapy | Astra Zeneca | CDER | Link to documents | |
| 71 st Meeting | 2/27/02 | Trial Design Considerations and Appropriate Patient Populations for Studies of Investigational Agents for Adjuvant Therapy of Melanoma Given the Availability of an Approved agent for this Indication | FDA | CBER | Link to documents | |||||
| 70th Meeting | 1/31/02 | 021386 /000 | Zometa | zolendronate | injection | Bone symptoms for multiple myeloma and solid tumors | Novartis | CDER | Link to documents | |
| 11/28/01 | Clinical Trial Considerations for Pediatric Oncology | FDA | CDER/CBER | Link to documents | ||||||
| 68th Meeting | 9/10//01 | Clinical Trial Considerations for Hormonal Therapy of Breast Cancer | FDA | CDER | Link to documents | |||||
| 9/10/01 | 021236 /000 | IntraDose | cisplatin-epinephrine gel | injection | Palliative therapy for head and neck cancer | Matrix | CDER | Link to documents | ||
| 6/28/01/01 | Pediatric Solid Tumors and CNS Malignancies- extrapolation from adult malignancies | FDA | CDER/CBER | Link to documents | ||||||
| 67th Meeting | 6/7/01 | Single Patient INDs- access to unapproved therapy | FDA | CDER | Link to documents | |||||
| 4/24/01 | Pediatric Hematological Malignancies- extrapolation from adult malignancies | FDA | CDER/CBER | Link to documents | ||||||
| 66th Meeting | 12/14/00 | Campath | humanized anti-CD52 monoclonal antibody | injection | Chronic Lyphocytic Leukemia-second line therapy following fludarabine | ILEX/Millenium | CBER | Link to documents | ||
| 66th Meeting | 12/14/00 | Single Patient INDs- access to unapproved therapy | FDA | CDER | Link to documents | |||||
| 66th Meething | 12/13/00 | 029726 /006 | Femara | letrozole | oral tablets | First-line treatment of postmenopausal women with hormone receptor positive or hormone receptor unknown locally advanced or metastatic breast cancer. | Novartis | CDER | Link to documents | |
| 66th Meeting | 12/13/00 | 021240 /000 | Hismanal | histamine dihydrochloride | injection | Melanoma - Adjunct to Interleukin-2 in Patients with Metastatic Melanoma | Maxim | CDER | Link to documents | |
| 9/12/00 | Pediatric Malignancies- Extrapolation from adults | FDA | CDER/CBER | Link to documents | ||||||
| 9/12/00 | Pediatric Malignancies- Extrapolation from adults-continued | FDA | CDER/CBER | Link to documents | ||||||
| 65th Meeting | 3/17/00 | 021174 /000 | Mylotarg | gemtuzimab zogomycin | injection | Leukemia- relapsed acute myeloid leukemia in patients over 60 who would not tolerate other therapy | Wyeth Ayerst | CDER | Yes | Link to documents |
| 65th Meeting | 3/16/00 | 021063 /000 | Eloxatin | oxaliplatin | injection | Colorectal cancer- first line therapy for colorectal cancer | Sanofi-Synthelabo | CDER | Link to documents | |
| 65th Meeting | 3/16/00 | 020571 /009 | Camptosar | irinotecan | injection | Colorectal cancer -first line therapy for colorectal cancer | Pharmacia & Upjohn | CDER | Link to documents | |
| 64th Meeting | 12/14/99 | 021156 /000 | Celebrex | celecoxib | oral tablets | Familial adenomatous polyposis-reduction and regression of adenomatous colorectal polyps in familial adenomatous polyposis patients | Searle | CDER | Yes | |
| 64th Meeting | 12/13/99 | 021055 /000 | Targretin | bexarotene | oral capsules | Lymphoma- cutaneous lymphoma | Ligand Pharamaceuticals | CDER | ||
| 64th Meeting | 12/13/99 | 020449 /011 | Taxotere | docetaxel | concentrate for injection | Lung cancer - Non Small Cell | Rhone Poulenc Rorer | CDER | ||
| 63rd Meeting | 9/17/99 | 020262 /033 | Taxol | paclitaxel | injection | Breast cancer- Node positive breast cancer | Bristol Myers Squibb | CDER | ||
| 63rd Meeting | 9/17/99 | 97-1001 /000 | Roferon-A | interferon | injection | Melanoma- surgically resected malignant melanoma | Hoffman LaRoche | CBER | ||
| 63rd Meeting | 9/16/99 | 021053 /000 | UFT | tegafur and uracil | capsules | Colorectal cancer- metastatic colorectal cancer | Bristol Myers Squibb | CDER | Link to documents | |
| 63rd Meeting | 9/16/99 | 050772 /000 | Evacet | liposomal doxorubicin | injection | Breast cancer- metastatic breast cancer | The Liposome Company | CDER | Link to documents | |
| 62nd Meeting | 6/8/99 | 050718 /006 | Doxil | liposomal doxorubicin | IV | Ovarian cancer -metastatic carcinoma of the ovary in patients with disease that is refractory to both paclitaxel- and platinum-based chemotherapy regimes | ALZA Corporation | CDER | Yes | |
| 62nd Meeting | 6/8/99 | 020221 /012 | Ethyol | amifostine | injection | Xerostomia- to reduce the incidence of moderate to severe xerostomia | US Bioscience | CDER | ||
| 62nd Meeting | 6/7/99 6/7/99 6/7/99 | 050595 /000 | Ellence | epirubicin HCl | injection | breast | Pharmacia & Upjohn | CDER | ||
| 62nd Meeting | 6/7/99 6/7/99 6/7/99 | Breast- Time to Progression as an End Point | FDA | CDER | ||||||
| 61st Meeting | 3/23/99 | 021051 /000 | Temodal | temozolomide | oral | Melanoma-for the first line treament of patients with advanced metastatic malignant melanoma | Schering Corporation | CDER | Link to documents | |
| 60th Meeting | 1/13/99 | 020954 /000 | Busulfex | bulsulfan | IV | Bone Marrow Transplant- Indicated for use in combination with other chemotherapeutic agents and/or radiotherapy as a conditioning regimen prior to hematopoietic progenitor cell transplantation. | Orphan Medical | CDER | ||
| 60th Meeting | 1/13/99 | 020765 /000 | OraTest | tolonium chloride | oral liquid | Oral cancers- diagnostic adjunct in patients with oral lesions suspected or known to be malignant, to help in detection of all sites of cancer and selection of sites to be biopsied | Zila, Inc. | CDER | ||
| 60th Meeting | 1/12/99 | 021029 021050 /000 | Temodal | temolzolomide | oral | anaplastic astrocytoma | Schering Corporation | CDER | Yes | |
| 60th Meeting | 1/12/99 | 050766 /000 | Prograf | tacrolimus | oral and IV | Graft versus Host Disease- prevention of acute Graft versus Host disease | Fujisawa Healthcare, Inc. | CDER | ||
| 59th Meeting | 11/16/98 | 021041 /000 | DepoCyt | cytarabine | injection | Lymphomatous meningitis | DepoTech | CDER | ||
| 59th Meeting | 11/16/98 | 020886 /000 | Panretin Gel | alitretinoin | topical gel | AIDS-related Kaposi's sarcoma -cutaneous lesions related to Kaposi's sarcoma | Ligand Pharmaceuticals Inc. | CDER | ||
| 58th Meeting | 9/3/98 | 020571 /008 | Camptosar | irinotecan | injection | Colorectal cancer- the treatment of metastatic carcinoma of the colon or rectum whose disease has progressed or recurred following 5-FU-based chemotherapy | Pharmacia & Upjohn | CDER | ||
| 58th Meeting | 9/3/98 | 020451 /003 | Photofrin for Injection | porfimer sodium | injection | non-small cell lung cancer- the reduction of obstruction and palliation of symptoms in patients with completely or partially obstructing non-small-cell lung cancer | QLT PhotoTherapeutics | CDER | ||
| 58th Meeting | 9/2/98 | 017970 /040 | Nolvadex | tamoxifen | oral | Breast cancer- risk reduction for breast cancer | Zeneca Pharmaceuticals | CDER | ||
| 58th Meeting | 9/2/98 | 980369 /000 | Herceptin | trastuzumab | injection | Breast cancer- Indicated for the treatment o patients with metastatic breast cancer who have tumors which overexpress HER2 | Genentech, Inc. | CBER | ||
| 58th Meeting | 9/1/98 | 020893 /000 | Metaret | suramin hexasodium | injection | Prostate cancer- Indicated for the treatment of patients with hormone refractory prostate cancer | Parke-Davis | CDER | ||
| 58th Meeting | 9/1/98 | 020892 /000 | Valstar | valrubicin | sterile solution for injection | Bladder cancer- treatment of patients with BCG refractory carcinoma in situ of the bladder | Anthra Pharmaceuticals | CDER | ||
| 57th Meeting | 6/2/98 | 971325 /000 | Ontak | denileukin diftitox | injection | Lymphoma- Indicated for the treatment of cutaneous T-cell lymphoma (CTCL) | Seragen, Inc. | CBER | ||
| 57th Meeting | 6/2/98 | 020671 /004 | Hycamtin | topotecan | IV infusion | Lung cancer-Small cell- Indicated for the second-line treatment of patients with small cell lung cancer | SmithKline Beecham Pharmaceuticals | CDER | ||
| 57th Meeting | 6/1/98 | 020892 /000 | Valstar | valrubicin | injection | bladder cancer- Indicated for the treatment of refractory carcinoma in situ of the urinary bladder | Anthra Pharmaceuticals | CDER | ||
| 57th Meeting | 6/1/98 | 020449 /005 | Taxotere | docetaxel | injection | Breast cancer- locally advanced or metastatic breast cancer | Rhone Polence Rorer Pharmaceuticals | CDER | ||
| 56th Meeting | 3/20/98 | 020262 /026 | Taxol | paclitaxel | injection | Ovarian cancer- Indicated as first-line therapy for the treatment of advanced carcinoma of the ovary. | Bristol-Myers Squibb Pharmaceutical Research Institute | CDER | ||
| 56th Meeting | 3/20/98 | 020262 /024 | Taxol | paclitaxel | injeciton | Lung cancer - Non Small Cell- For the treatment of non-small cell lung cancer in patients who are not candidates for potentially curative and/or radiation therapy | Bristol-Myers Squibb Pharmaceutical Research Institute | CDER | ||
| 56th Meeting | 3/19/98 | 020509 /005 | Gemzar | gemcitabine | injection | Lung cancer - Non Small Cell - Indicated as a single agent or in combination with cisplatin for the first-line treatment of patients with locally advanced (Stage IIIA or Stage IIIB) or metastatic (Stage IV) non-small cancer of the lung. | Eli Lilly and Company | CDER | ||
| 56th Meeting | 3/19/98 | 020896 /000 | Xeloda | capecitabine | oral tablets | Breast cancer- Indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of paclitaxel and an anthracycline-containing chemotherapy | Hoffman-LaRoche | CDER | ||
| 55th Meeting | 12/19/97 | 020806 /000 | Neomark | broxuridine | injection | Breast cancer- For use as a cell proliferation marker to determine labeling index in breast cancer | NeoPharm Inc. | CDER | ||
| 55th Meeting | 12/18/97 | 020798 /000 | Depocyte | cytarabine liposomal | injection | Carcinomatous meningitis- For the intrathecal treatment of neoplastic meningitis of patients with solid tumors, lymphoma or leukemia. | DepoTech Corporation | CDER | Yes | |
| 55th Meeting | 12/18/97 | 016295 /029 | Droxia | hydoxyurea | oral capsules | Sickle cell anemia- Indicated in the treatment of sickle cell anemia in adult patients to prevent painful crises and to reduce the need for blood transfusions | Bristol-Myers Squibb | CDER | ||
| 54th Meeting | 9/19/97 | 020826 /000 | Paxene | paclitaxel | injection | AIDS-related Kaposi's sarcoma- Indicated after failure of first line or subsequent systemic chemotherapy for the treatment of advanced AIDS-related Kaposi's sarcoma. | Baker-Norton Pharmaceuticals, Inc. | CDER | ||
| 54th Meeting | 9/18/97 | 020451 /022 | Photofrin | porfimer sodium) | injection | Lung cancer - Non Small Cell- For: a) reduction of obstruction and palliation of symptoms in patients with completely or partially obstructing endobronchial non small cell lung cancer (NSCLC) and b) treatment of endobronchial carcinoma | QLT Photo Therapeutics Inc. | CDER | ||
| 54th Meeting | 9/18/97 | 020817 /000 | Rivizor | vorozole | Breast cancer- The treatment of advanced breast cancer in postmenopausal women (natural or artificially-induced menopause) with disease progression following antiestrogen therapy. | Janssen | CDER | |||
| 53rd Meeting | 6/24/97 | /000 | Discussion of guidance: evidence of effectiveness | FDA | ||||||
| 53rd Meeting | 6/24/97 | 020794 /000 | Liazal | liarozole | oral tablet | Prostate cancer- advanced prostate cancer in pts who relapsed after first line hormonal tx. | Janssen | CDER | ||
| 53rd Meeting | 6/23/97 | 020262 /022 | Taxol | paclitaxel | injection | AIDS-related Kaposi's sarcoma second-line tx of AIDS-related KS | Bristol-Myers Squibb Pharmaceutical Research Institute | CDER | ||
| 53rd Meeting | 6/23/97 | 020709 /000 | Zyrkamine | mitoguazone | IV infusion | Lymphoma- AIDS related non-Hodgkin's- tx of AIDS-related NHL in pts who have been previously tx w/ at least one potentially curative regimen | Ilex Onc. | CDER | ||
| 52nd Meeting | 12/16/96 | 020726 /000 | Femara | letrozole | oral tablets | Breast cancer- postmenopausal women w/ receptor positive or unknown advanced breast cancer which has progressed on/after antiestrogen therapy | Ciba-Geigy | CDER | ||
| 52nd Meeting | 12/16/96 | 920306 /000 | TICE | BCG Vaccine | injection | Bladder cancer- intravesical installation for prophylaxis against recurrent papillary carcinoma of the urinary bladder | Organon Teknika | CBER | ||
| 10/21/96 | /000 | Discussion of Oncology initiatives | FDA | |||||||
| 51st Meeting | 9/11/96 | 020660 /000 | Remisar | bropirimine | oral | Bladder cancer carc. in situ (CIS) after failure of BCG therapy | Upjohn | CDER | ||
| 51st Meeting | 9/11/96 | 019297 /014 | Novantrone | mitoxantrone | injection | Prostate cancer- for use in combination with corticosteroids as initial chemotx for prostate cancer after failure of primary hormonal tx. | Immunex | CDER | ||
| 50th Meeting | 6/14/96 | 020637 /000 | Gliadel Wafer | carmustine implant | biodegradable polyanhydride wafer | Glioblastoma multiforme- adjunct to surgery to prolong survival in patients with malignant glioma | Guilford | CDER | ||
| 50th Meeting | 6/14/96 | /000 | closed session/update | FDA | ||||||
| 50th Meeting | 6/13/96 | 020036 /011 | Aredia | pamidronate | IV infusion | Bone metastases- in conjunction with standard therapy for treatment of osteolytic bone metastases | Ciba-Geigy | CDER | ||
| 50th Meeting | 6/13/96 | 020571 /000 | Camptosar | ironotecan HCL | injection | Colorectal cancer- metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following 5-FU-based therapy. | Upjohn | CDER | Yes | |
| 4/16/96 | 020671 /000 | Hycamtin | topotecan | Ovarian cancer- metastatic ovarian cancer after failure of initial or subsequent chemotherapy | SmithKline Beecham | CDER | Yes | |||
| 4/16/96 | /000 | Cancer Liaison Program | FDA | |||||||
| 2/14/96 | 020515 /000 | Zoladex | goserelin | Breast cancer- palliative tx of advanced breast ca. in pre- and perimenopausal women. | Zeneca | |||||
| 12/14/95 | 020587 /000 | Sterile Aerosol Talc | Pleural effusions- sclerosing agent for treatment of malignant pleural effusions (MPE) | Bryan | ||||||
| 12/14/95 | 940308 /000 | NR-LU-10 | 99 mTc... Fab whole body imaging | Lung cancer-Small cell -for primary staging of patients with biopsy confirmed SCLC | Karl Tomae | CBER | ||||
| 10/17/95 | 910209 /000 | CEA-Scan | arcitumomab | Colorectal cancer -diagnostic imaging in pre-surgical pts who are being considered for resection of recurrent/metastatic colorectal ca.,and, in combination with standard diagnostic modalities for accurate localization of CEA-producing colorectal cancers | Immunomedics | |||||
| 10/17/95 | 020449 /000 | Taxotere | docetaxel | Breast cancer- women w/ locally advanced or metastatic breast carc. in whom previous therapy has failed; prior therapy should have included an anthracycline unless clinically contraindicated | Rhone Poulenc Rorer | |||||
| 10/16/95 | 020497 /000 | Fareston | toremifene | Breast cancer- advanced breast cancer in postmenopausal women | Orion | |||||
| 10/16/95 | 020541 /000 | Arimidex | anastrozole | oral tablet | Breast cancer- women w/ postmenopausal advanced breast cancer who develop progressive disease while receiving Tamoxifen | Zeneca | ||||
| 7/25/95 | 940799 /000 | Intron A | interferon alpha 2b | Melanoma- post-op. adjuvant tx in malignant melanoma | Schering | |||||
| 7/24/95 | 020036 /000 | Aredia | pamidronate | Multiple myeloma- bone metastases associated with multiple myeloma | Ciba-Geigy | |||||
| 7/24/95 | 020509 /000 | Gemzar | gemcitabine | Pancreatic cancer- first line treatment of advanced or metastatic adenocarc. of the pancreas and 5-FU refractory pancreatic ca. | Lilly | |||||
| 6/9/95 | 020221 /000 | Ethyol | amifostine | Chemoprotection- against the cumulative renal tox. assoc. w/ cisplatin and the cumulative hematologic tox. assoc with cyclophosphamide and cisplatin in patients with advanced solid tumors of non-germ cell origin | US Bioscience | |||||
| 6/8/95 | 050704 /000 | Daunoxome | duanorubicn liposomal | injection | AIDS-related Kaposi's sarcoma - primary therapy for the palliative mgmt of advanced, HIV-assoc. Kaposi's sarcoma | Vestar | ||||
| 6/8/95 | /000 | closed session/ update | FDA | |||||||
| 4/10/95 | /000 | Interferon alpha-2a | Leukemia-tx. of chronic phase, Philadelphia chromosome positive chronic myelogenous leuk. (CML) | |||||||
| 4/10/95 | /000 | sargramostim (GM-CSF) | Neutropenia- acceleration of neutrophil recovery following allogeneic BMT, chemotx in acute nonlymphoblastic leukemia and for chemtx induced neutropenia | Immunex | ||||||
| 2/24/95 | 020169 /000 | Nilandron | nilutamide | Prostate cancer- Hormonal treatment of Stage D prostate cancer | Roussel Uclaf | |||||
| 2/14/95 | 050718 /000 | Doxil | doxorubicin liposomal | injection | AIDS-related Kaposi's sarcoma in patients who have failed prior systemic combo. chemotx either due to progression of dis. or unacceptable tox. | Liposome Tech | ||||
| 12/13/94 | 020449 /000 | Taxotere | docetaxel | Breast cancer- locally advanced or metastatic breast carc. that has failed previous therapy including an anthracycline; locally advanced or metastatic NSCLungC after failure of platinum-based chemotx. | Rhone Poulenc Rorer | |||||
| 12/13/94 | 020438 /000 | Vesanoid | tretinoin/ATRA. | Leukemia- tx. of acute promyelocytic leukemia; induction of remission in pts who are resistant to or are contraindicated for anthracycline-based chemotx or have relapsed after entering remission induced by chemotx. | Roche | Yes | ||||
| 12/12/94 | 020221 /000 | Ethyol | amifostine | Chemoprotection- cytoprotective agent against both the acute and cumulative hematologic and renal toxicities assoc. w/ alkylating agents such as cyclophosphamide, and platinum agents such as cisplatin, in pts wi/ ovarian ca. | US Bioscience | |||||
| 12/12/94 | 020212 /000 | Zinecard | dexrazoxane/ | Chemoprotection- preventing/reducing the incidence and severity of cardiomyopathy assoc. w/ doxorubicin administration in pts who have received potentially cardiotoxic doses of dox. and who would benefit from continuing tx. w/ dox. | Pharmacia | |||||
| 9/12/94 | 020451 /000 | Photofrin | porfimer Na | Esophageal cancer- reduction of obstruction and palliation of dysphagia in pts w/ completely or partially obstructing esophageal ca. | QLT | |||||
| 9/12/94 | /000 | closed session | FDA | |||||||
| 6/24/94 | /000 | Breast cancer- Proposed clinical study of hormonal contraceptive intended to prevent breast cancer. | FDA | |||||||
| 6/7/94 | /000 | tamoxifen | oral tablet | Breast cancer- NSABP breast cancer prevention trial | Zeneca/NSABP/NCI | |||||
| 6/7/94 | 020445 /000 | Navelbine | vinorelbine | Breast cancer- metastatic breast cancer that has failed standard chemotx= metastatic breast cancer relapsed within 6 months of anthracycline-based adjuv. tx. | Burroughs Wellcome | |||||
| 5/25/94 | /000 | Neutropenia - hematopoietic stem cell support in myelotoxic chemotx. | FDA | |||||||
| 12/15/93 | 020388 /000 | Navelbine | vinorelbine | Lung cancer - Non Small Cell- single agent or in combo. for tx of unresectable advanced NSCLungC | Burroughs Wellcome | |||||
| 12/15/93 | 020262 /000 | Taxol | paclitaxel | injection | Breast cancer- supplement: after failure of first line chemotx or subsequent chemotx for metastatic breast ca. | Bristol Myers Squibb | ||||
| 9/23/93 | 020262 /000 | Taxol | paclitaxel | injection | Ovarian cancer- supplement: increase dose, decrease infusion time | Bristol Myers Squibb | ||||
| 9/23/93 | 050443 /000 | Blenoxane | bleomycin | Pleural effusions- supplement: sclerosing agent for tx of malignant pleural effusions (MPE) and prevention of recurrent pleural effusions. | Bristol Myers Squibb | |||||
| 9/23/93 | /000 | closed session | FDA |