From: Chapter 45, Preclinical and Early Clinical Development of New Anticancer Agents
Copyright © 2003, BC Decker Inc.
NCBI Bookshelf. A service of the National Library of Medicine, National Institutes of Health.
Kufe DW, Pollock RE, Weichselbaum RR, et al., editors. Holland-Frei Cancer Medicine. 6th edition. Hamilton (ON): BC Decker; 2003.
Holland-Frei Cancer Medicine. 6th edition.
Show detailsTable 45-1FDA-Approved Anticancer Agents and Their Indications a
| Generic Name | Tradename (Company) | Indication | Yearb |
|---|---|---|---|
| Aldesleukin | Proleukin (Chiron) | Adults with metastatic renal cell carcinoma | 1992 |
| Adults with metastatic melanoma | |||
| Alemtuzumab | Campath (Berlex) | Treatment of B-cell chronic lymphocytic leukemia (B-CLL) in patients who have been treated with alkylating agents and who have failed fludarabine therapy | 2001 |
| Alitretinoin | Panretin (Ligand) | Topical treatment of cutaneous lesions in patients with AIDS-related Kaposi sarcoma (KS), not indicated when systemic anti-KS therapy is required | 1999 |
| Altretamine | Hexalen (MGI Pharma) | Single agent in the palliative treatment of patients with persistent or recurrent ovarian cancer following first-line therapy with a cisplatin and/or alkylating agent-based combination | 1990 |
| Aminolevulinic acid | Levulan Kerastick (Berlex) | Nonhyperkeratotic actinic keratoses of the face or scalp | 1999 |
| Anagrelide | Agrylin (Shire) | Thrombocythemia, secondary to myeloproliferative disorders, to reduce the elevated platelet count and the risk of thrombosis and to ameliorate associated symptoms including thrombohemorrhagic events | 1997 |
| Anastrozole | Arimidex (AstraZeneca) | First-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor unknown locally advanced or metastatic breast cancer | 1995 |
| Advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy | |||
| Arsenic trioxide | Trisenox (Cell Therapeutics) | Induction of remission and consolidation in patients with acute promyelocytic leukemia (APL) who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy and whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression | 2000 |
| Asparaginase | Elspar (Merck) | Acute lymphocytic leukemia, combination with other chemotherapeutic agents in the induction of remissions in pediatric patients | 1978 |
| Bacille Calmette-Guérin (BCG) | TheraCys (Aventis Pasteur) Tice BCG (Organon) PACIS (UroCor) | TheraCys, Tice- treatment and prophylaxis of carcinoma in situ (CIS) of the urinary bladder, prophylaxis of primary or recurrent stage Ta and/or T1 papillary tumors following transurethral resection (TUR) | 1990 |
| PACIS- CIS in the absence of an associated invasive cancer of the bladder in the following situations: (1) primary treatment of CIS with or without papillary tumors after TUR, (2) secondary treatment of CIS in patients failing to respond or relapsing after intravesical therapy with other agents, (3) primary or secondary treatment of CIS for patients with medical contraindications to radical surgery | |||
| Betamethasone | Celestone, Celestone Soluspan (Schering) | Hypercalcemia associated with cancer, mycosis fungoides, idiopathic thrombocytopenic purpura in adults, secondary thrombocytopenia in adults, erythroblastopenia, palliative management of leukemias and lymphomas in adults, palliative management of acute leukemia of childhood | 1961 |
| Bexarotene | Targretin (Ligand) | Oral-cutaneous manifestations of cutaneous T-cell lymphoma in patients who are refractory to at least one prior systemic therapy | 1999 |
| Topical-patients with cutaneous T-cell lymphoma (stage IA and IB) who have refractory or persistent disease after other therapies or who have not tolerated other therapies | |||
| Bicalutamide | Casodex (AstraZeneca) | Combination therapy with a luteinizing hormone-releasing hormone analog for the treatment of stage D2 metastatic carcinoma of the prostate | 1995 |
| Bleomycin | Blenoxane (Bristol-Myers Squibb) Bleomycin (Pharmacia) | Palliative treatment of squamous cell carcinoma: head and neck (including mouth, tongue, tonsil, nasopharynx, oropharynx, sinus, palate, lip, buccal mucosa, gingiva, epiglottis, skin, larynx), penis, cervix, and vulva | 1973 |
| Palliative treatment of lymphomas: Hodgkin's, reticulum cell sarcoma, lymphosarcoma | |||
| Palliative treatment of testicular carcinoma: embryonal cell, choriocarcinoma, and teratocarcinoma | |||
| Blenoxane only-malignant pleural effusion and prevention of recurrent pleural effusions | |||
| Busulfan | Busulfex (Orphan Medical) Myleran (GlaxoSmithKline) | Busulfex-combination with cyclophosphamide as a conditioning regimen prior to allogeneic hematopoietic progenitor cell transplantation for chronic myelogenous leukemia | 1954 |
| Myleran-palliative treatment of chronic myelogenous (myeloid, myelocytic, granulocytic) leukemia | |||
| Capecitabine | Xeloda (Roche) | Metastatic breast cancer resistant to both paclitaxel and an anthracycline-containing chemotherapy regimen or resistant to paclitaxel and for whom further anthracycline therapy is not indicated | 1998 |
| Carboplatin | Paraplatin (Bristol-Myers Squibb) | Initial treatment of advanced ovarian carcinoma in established combination with other approved chemotherapeutic agents | 1989 |
| Palliative treatment of patients with ovarian carcinoma recurrent after prior chemotherapy, including patients who have been previously treated with cisplatin | |||
| Carmustine | BiCNU (Bristol-Myers Squibb) | Palliative therapy as a single agent or in established combination therapy with other approved chemotherapeutic agents in: glioblastoma, brainstem glioma, medulloblastoma, astrocytoma, ependymoma, and metastatic brain tumors | 1977 |
| Multiple myeloma—in combination with prednisone | |||
| Hodgkin's disease—as secondary therapy in combination with other approved drugs in patients who relapse while being treated with primary therapy or who fail to respond to primary therapy | |||
| Non-Hodgkin's lymphomas—as secondary therapy in combination with other approved drugs for patients who relapse while being treated with primary therapy or who fail to respond to primary therapy | |||
| Chlorambucil | Leukeran (GlaxoSmithKline) | Chronic lymphatic (lymphocytic) leukemia, malignant lymphomas including lymphosarcoma, giant follicular lymphoma, and Hodgkin's disease | 1957 |
| Chromic phosphate P-32 | Phosphocol P-32 (Mallinckrodt) | Peritoneal or pleural effusions caused by metastatic disease, and may be injected interstitially for the treatment of cancer | 1974 |
| Cisplatin | Platinol-AQ (Bristol-Myers Squibb) | Metastatic testicular tumors: in established combination therapy with other approved chemotherapeutic agents in patients with metastatic testicular tumors who have already received appropriate surgical and/or radiotherapeutic procedures | 1978 |
| Metastatic ovarian tumors: in established combination therapy with other approved chemotherapeutic agents in patients with metastatic ovarian tumors who have already received appropriate surgical and/or radiotherapeutic procedures; single agent is indicated as secondary therapy in patients with metastatic ovarian tumors refractory to standard chemotherapy who have not previously received cisplatin | |||
| Advanced bladder cancer: single agent for patients with transitional cell bladder cancer that is no longer amenable to local treatments such as surgery and/or radiotherapy | |||
| (Non-small-cell lung cancer: see gemcitabine, paclitaxel, vinorelbine) | |||
| Cladribine | Leustatin (Ortho Bio-Tech) | Active hairy cell leukemia as defined by clinically significant anemia, neutropenia, thrombocytopenia, or disease-related symptoms | 1993 |
| Conjugated estrogens | Premarin (Wyeth-Ayerst) | Breast cancer (for palliation only) in appropriately selected women and men with metastatic disease | 1938 |
| Advanced androgen-dependent carcinoma of the prostate (for palliation only) | |||
| Cortisone | Cortone (Merck) | Hypercalcemia associated with cancer, mycosis fungoides, idiopathic thrombocytopenic purpura in adults, secondary thrombocytopenia in adults, erythroblastopenia, palliative management of leukemias and lymphomas in adults, palliative management of acute leukemia of childhood | 1950 |
| Cyclophosphamide | Cytoxan (Bristol-Myers Squibb) Neosar (Pharmacia) | Malignant lymphomas (stages III and IV of the Ann Arbor staging system), Hodgkin's disease, lymphocytic lymphoma (nodular or diffuse), mixed-cell type lymphoma, histiocytic lymphoma, Burkitt lymphoma | 1959 |
| Leukemias: chronic lymphocytic leukemia, chronic granulocytic leukemia (it is usually ineffective in acute blastic crisis), acute myelogenous and monocytic leukemia, acute lymphoblastic (stem cell) leukemia in children (cyclophosphamide given during remission is effective in prolonging its duration) | |||
| Multiple myeloma, mycosis fungoides (advanced disease), neuroblastoma (disseminated disease), adenocarcinoma of the ovary, retinoblastoma, carcinoma of the breast | |||
| Cytarabine liposome | DepoCyt (Chiron) | Intrathecal treatment of lymphomatous meningitis | 1999 |
| Cytarabine, ara-C | Cytosar-U (Pharmacia) | Combination with other approved anticancer drugs for remission induction in acute nonlymphocytic leukemia of adults and pediatric patients; it has also been found useful in the treatment of acute lymphocytic leukemia and the blast phase of chronic myelocytic leukemia; intrathecal administration of cytarabine is indicated in the prophylaxis and treatment of meningeal leukemia | 1969 |
| Dacarbazine | DTIC-Dome (Bayer) | Metastatic malignant melanoma | 1975 |
| Hodgkin's disease as a second-line therapy when used in combination with other effective agents | |||
| Dactinomycin, actinomycin D | Cosmegen (Merck) | Wilms tumor, rhabdomyosarcoma, carcinoma of testis and uterus, palliative treatment of Ewing sarcoma and sarcoma botryoides | 1964 |
| Daunorubicin | Cerubidine (Bedford) | Combination with other approved anticancer drugs for remission induction in acute nonlymphocytic leukemia (myelogenous, monocytic, erythroid) of adults and for remission induction in acute lymphocytic leukemia of children and adults | 1979 |
| Daunorubicin citrate liposome | Daunoxome (Gilead Sciences) | First-line cytotoxic therapy for advanced HIV-associated Kaposi sarcoma | 1996 |
| Denileukin diftitox | Ontak (Ligand) | Patients with persistent or recurrent cutaneous T-cell lymphoma whose malignant cells express the CD25 component of the IL-2 receptor | 1999 |
| Dexamethasone | Decadron (Merck) | Hypercalcemia associated with cancer, mycosis fungoides, idiopathic thrombocytopenic purpura in adults, secondary thrombocytopenia in adults, erythroblastopenia, palliative management of leukemias and lymphomas in adults, palliative management of acute leukemia of childhood | 1958 |
| Diclofenac | Solaraze (SkyePharma) | Topical treatment of actinic keratoses | 2000 |
| Docetaxel | Taxotere (Aventis) | Locally advanced or metastatic breast cancer after failure of prior chemotherapy | 1996 |
| Locally advanced or metastatic non-small cell lung cancer after failure of prior platinum-based chemotherapy | |||
| Doxorubicin | Adriamycin (Pharmacia) Rubex (Bristol-Myers Squibb) | Acute lymphoblastic leukemia, acute myeloblastic leukemia, Wilms tumor, neuroblastoma, soft-tissue and bone sarcomas, breast carcinoma, ovarian carcinoma, transitional cell bladder carcinoma, | 1974 |
| thyroid carcinoma, gastric carcinoma, Hodgkin's disease, malignant lymphoma, and bronchogenic carcinoma in which the small cell histologic type is the most responsive compared to other cell types | |||
| Doxorubicin liposome | Doxil (Alza) | Metastatic carcinoma of the ovary in patients with disease that is refractory to both paclitaxel- and platinum-based chemotherapy regimens | 1995 |
| AIDS-related Kaposi sarcoma in patients with disease that has progressed on prior combination chemotherapy or in patients who are intolerant to such therapy | |||
| Epirubicin | Ellence (Pharmacia) | Adjuvant therapy in patients with evidence of axillary node tumor involvement following resection of primary breast cancer | 1999 |
| Esterified estrogens | Estratab (Solvay) | Breast cancer (for palliation only) in appropriately selected women and men with metastatic disease | 1938 |
| Menest (Monarch) | Advanced androgen-dependent carcinoma of the prostate (for palliation only) | ||
| Estradiol | Estrace (Bristol-Myers Squibb) | Breast cancer (for palliation only) in appropriately selected women and men with metastatic disease | 1938 |
| Advanced androgen-dependent carcinoma of the prostate (for palliation only) | |||
| Estradiol valerate | Delestrogen (Bristol-Myers Squibb) | Advanced androgen-dependent carcinoma of the prostate (for palliation only) | 1938 |
| Estramustine | Emcyt (Pharmacia) | Palliative treatment of patients with metastatic and/or progressive carcinoma of the prostate | 1981 |
| Estrone | Estrone (generic) | Breast cancer (for palliation only) in appropriately selected women and men with metastatic disease | |
| Advanced androgen-dependent carcinoma of the prostate (for palliation only) | 1938 | ||
| Ethinyl estradiol | Estinyl (Schering) | Breast cancer (for palliation only) in appropriately selected women and men with metastatic disease | 1943 |
| Advanced androgen-dependent carcinoma of the prostate (for palliation only) | |||
| Etoposide | Toposar (Pharmacia) VePesid (Bristol-Myers Squibb) | Injection- combination therapy with other approved chemotherapeutic agents in patients with refractory testicular tumors who have already received appropriate surgical, chemotherapeutic and radiotherapeutic therapy | |
| Injection/Oral-combination with other approved chemotherapeutic agents as first-line treatment in patients with small cell lung cancer | 1983 | ||
| Etoposide phosphate | Etopophos (Bristol-Myers Squibb) | Combination therapy with other approved chemotherapeutic agents in patients with refractory testicular tumors who have already received appropriate surgical, chemotherapeutic, and radiotherapeutic therapy | 1996 |
| Combination with other approved chemotherapeutic agents as first-line treatment in patients with small cell lung cancer | |||
| Exemestane | Aromasin (Pharmacia) | Advanced breast cancer in postmenopausal women whose disease has progressed following tamoxifen therapy | 1999 |
| Floxuridine | FUDR (Roche) | Palliative management of gastrointestinal adenocarcinoma metastatic to the liver, when given by continuous regional intra-arterial infusion in carefully selected patients who are considered incurable by surgery or other means | 1970 |
| Fludarabine phosphate | Fludara (Berlex) | Patients with B-cell chronic lymphocytic leukemia (CLL) who have not responded to or whose disease has progressed during treatment with at least one standard alkylating-agent containing regimen | 1991 |
| Fluorouracil | Adrucil (Pharmacia) | Palliative management of carcinoma of the colon, rectum, breast, stomach, and pancreas | 1962 |
| Fluorouracil | Efudex (ICN) | Topical treatment of actinic or solar keratoses; in the 5% strength, it is also useful in the treatment of superficial basal cell carcinomas when conventional methods are impractical | 1962 |
| Fluorouracil | Fluoroplex (Allergan) | Topical treatment of multiple actinic (solar) keratoses | 1962 |
| Fluoxymesterone | Halotestin (Pharmacia) | Palliation of androgen-responsive recurrent mammary cancer in women who are more than 1 year but less than 5 years postmenopausal or who have been proven to have a hormone-dependent tumor as shown by previous beneficial response to castration | 1956 |
| Flutamide | Eulexin (Schering) | Combination with LHRH agonists for the management of locally confined stage B2-C and stage D2 metastatic carcinoma of the prostate | 1989 |
| Gemcitabine | Gemzar (Eli Lilly) | Combination with cisplatin for the first-line treatment of patients with inoperable, locally advanced (stage IIIA or IIIB) or metastatic (stage IV) non-small-cell lung cancer | 1996 |
| First-line treatment for patients with locally advanced (nonresectable stage II or stage III) or metastatic (stage IV) adenocarcinoma of the pancreas; Gemzar is indicated for patients previously treated with 5-FU | |||
| Gemtuzumab ozogamicin | Mylotarg (Wyeth-Ayerst) | Patients with CD33-positive acute myeloid leukemia in first relapse who are 60 years of age or older and who are not considered candidates for cytotoxic chemotherapy | 2000 |
| Goserelin acetate | Zoladex (AstraZeneca) | Palliative treatment of advanced carcinoma of the prostate in combination with flutamide for the management of locally confined stage T2b-T4 (stage B2-C) carcinoma of the prostate | 1989 |
| Palliative treatment of advanced breast cancer in pre- and perimenopausal women | |||
| Granisetron | Kytril (Roche) | Prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer therapy, including high-dose cisplatin | 1993 |
| Hydrocortisone | Cortef, Solu-Cortef (Pharmacia) Hydrocortone (Merck) | Hypercalcemia associated with cancer, mycosis fungoides, idiopathic thrombocytopenic purpura in adults, secondary thrombocytopenia in adults, erythroblastopenia, palliative management of leukemias and | 1951 |
| lymphomas in adults, palliative management of acute leukemia of childhood | |||
| Hydroxyprogesterone | Hydroxyprogesterone (Schein) | Endometrial cancer | 1956 |
| Hydroxyurea | Hydrea (Bristol-Myers Squibb) | Melanoma, resistant chronic myelocytic leukemia, and recurrent, metastatic, or inoperable carcinoma of the ovary | 1967 |
| Hydroxyurea used concomitantly with irradiation therapy is intended for use in the local control of primary squamous cell (epidermoid) carcinomas of the head and neck, excluding the lip | |||
| Ibritumomab tiuxetan | Zevalin (IDEC) | Patients with relapsed or refractory low-grade, follicular, or transformed B-cell non-Hodgkin's lymphoma, including patients with rituximab refractory follicular non-Hodgkin's lymphoma | 2002 |
| Idarubicin | Idamycin (Pharmacia) | Combination with other approved antileukemic drugs for the treatment of acute myeloid leukemia in adults; this includes French-American-British classifications M1 through M7 | 1990 |
| Ifosfamide | Ifex (Bristol-Myers Squibb) | Combination with certain other approved antineoplastic agents for third-line chemotherapy of germ cell testicular cancer; it should ordinarily be used in combination with a prophylactic agent for hemorrhagic cystitis, such as mesna | 1992 |
| Imatinib mesylate | Gleevec (Novartis) | Patients with Philadelphia chromosome positive chronic myeloid leukemia (CML) in blast crisis, accelerated phase, or in chronic phase after failure of interferon-α therapy; Gleevec is also indicated for the treatment of patients with Kit (CD117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumors (GIST) | 2001 |
| Interferon alfa-2a | Roferon-A (Roche) | Hairy cell leukemia, AIDS-related Kaposi sarcoma in patients 18 years of age or older, and chronic phase, Philadelphia chromosome-positive chronic myelogenous leukemia patients who are minimally pretreated (within 1 yr of diagnosis) | 1986 |
| Interferon alfa-2b | Intron A (Schering) | Patients 18 years of age or older with hairy cell leukemia | 1986 |
| Adjuvant to surgical treatment in patients 18 years of age or older with malignant melanoma who are free of disease but at high risk for systemic recurrence, within 56 days of surgery | |||
| Clinically aggressive follicular non-Hodgkin's lymphoma in conjunction with anthracycline-containing combination chemotherapy in patients 18 yr of age or older | |||
| Patients 18 yr of age or older with AIDS-related Kaposi sarcoma | |||
| Irinotecan | Camptosar (Pharmacia) | First-line therapy in combination with 5-fluorouracil and leucovorin for patients with metastatic carcinoma of the colon or rectum | 1996 |
| Metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial fluorouracil-based therapy | |||
| Letrozole | Femara (Novartis) | First-line treatment of postmenopausal women with hormone receptor positive or hormone receptor unknown locally advanced or metastatic breast cancer; Femara is also indicated for the treatment of advanced breast cancer in postmenopausal women with disease progression following antiestrogen therapy | 1997 |
| Leuprolide acetate | Lupron, Lupron Depot (TAP) | Palliative treatment of advanced prostate cancer | 1985 |
| Viadur (Bayer) | |||
| Levothyroxine | Unithroid (Jerome Stevens) | Pituitary TSH suppression—as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer | 2000 |
| Lomustine | CeeNU (Bristol-Myers Squibb) | Single agent in addition to other treatment modalities or in established combination therapy with other approved chemotherapeutic agents in: | 1977 |
| Brain tumors (both primary and metastatic) in patients who have already received appropriate surgical and/or radiotherapeutic procedures | |||
| Hodgkin's disease: secondary therapy in combination with other approved drugs in patients who relapse while being treated with primary therapy or who fail to respond to primary therapy | |||
| Mechlorethamine | Mustargen (Merck) | Palliative treatment of Hodgkin's disease (stages III and IV), lymphosarcoma, chronic myelocytic or chronic lymphocytic leukemia, polycythemia vera, mycosis fungoides, and bronchogenic carcinoma and metastatic carcinoma resulting in effusion | 1949 |
| Medroxyprogesterone | Depo-Provera (Pharmacia) | Adjunctive therapy and palliative treatment of inoperable, recurrent, and metastatic endometrial or renal carcinoma | 1959 |
| Medroxyprogesterone | Provera (Pharmacia) | To reduce the incidence of endometrial hyperplasia in nonhysterectomized postmenopausal women receiving 0.625 mg conjugated estrogen | 1959 |
| Megestrol acetate | Megace (Bristol-Myers Squibb) | Palliative treatment of advanced carcinoma of the breast or endometrium | 1971 |
| Melphalan | Alkeran (GlaxoSmithKline) | Oral-palliative treatment of multiple myeloma and nonresectable epithelial carcinoma of the ovary | 1964 |
| Injection-palliative treatment of patients with multiple myeloma for whom oral therapy is not appropriate | |||
| Mercaptopurine | Purinethol (GlaxoSmithKline) | Remission induction and maintenance therapy of acute lymphatic leukemia | 1953 |
| Acute myelogenous (and acute myelomonocytic) leukemia | |||
| Methotrexate sodium | methotrexate (Immunex) | Treatment of gestational choriocarcinoma, chorioadenoma destruens, and hydatidiform mole | 1953 |
| In acute lymphocytic leukemia, methotrexate is indicated in the prophylaxis of meningeal leukemia and is used in maintenance therapy in combination with other chemotherapeutic agents; methotrexate is also indicated in the treatment of meningeal leukemia | |||
| Methotrexate is used alone or in combination with other anticancer agents in the treatment of breast cancer, epidermoid cancers of the head and neck, advanced mycosis fungoides, and lung cancer, particularly squamous cell and small cell types; methotrexate is also used in combination with other chemotherapeutic agents in the treatment of advanced stage non-Hodgkin's lymphomas | |||
| Methotrexate in high doses followed by leucovorin rescue in combination with other chemotherapeutic agents is effective in prolonging relapse-free survival in patients with nonmetastatic osteosarcoma who have undergone surgical resection or amputation for the primary tumor | |||
| Methoxsalen | 8-MOP (ICN) Uvadex (Therakos) | Photopheresis in the palliative treatment of the skin manifestations of cutaneous T-cell lymphoma in persons who have not been responsive to other forms of treatment | 1954 |
| Methylprednisolone | Depo-Medrol, Medrol, Solu-Medrol (Pharmacia) | Hypercalcemia associated with cancer, mycosis fungoides, idiopathic thrombocytopenic purpura in adults, secondary thrombocytopenia in adults, erythroblastopenia, palliative management of leukemias and lymphomas in adults, palliative management of acute leukemia of childhood | 1957 |
| Methyltestosterone | Android, Testred (ICN) | Secondarily in women with advancing inoperable metastatic (skeletal) mammary cancer who are 1 to 5 yr postmenopausal | 1939 |
| Metyrosine | Demser (Merck) | Chronic treatment of patients with malignant pheochromocytoma | 1979 |
| Mitomycin, mitomycin-c | Mutamycin (Bristol-Myers Squibb) | Disseminated adenocarcinoma of the stomach or pancreas in proven combinations with other approved chemotherapeutic agents and as palliative treatment when other modalities have failed | 1974 |
| Mitotane | Lysodren (Bristol-Myers Squibb) | Inoperable adrenal cortical carcinoma of both functional and nonfunctional types | 1970 |
| Mitoxantrone | Novantrone (Immunex) | In combination with corticosteroids as initial chemotherapy for the treatment of patients with pain related to advanced hormone-refractory prostate cancer | 1987 |
| In combination with other approved drug(s) in the initial therapy of acute nonlymphocytic leukemia in adults; this category includes myelogenous, promyelocytic, monocytic, and erythroid acute leukemias | |||
| Nandrolone phenpropionate | nandrolone (generic) | Secondarily in women with advancing inoperable metastatic (skeletal) mammary cancer who are 1 to 5 yr postmenopausal | 1959 |
| Nilutamide | Nilandron (Aventis) | Combination with surgical castration for the treatment of metastatic prostate cancer (stage D2) | 1996 |
| Octreotide acetate | Sandostatin, Sandostatin LAR Depot (Novartis) | Severe diarrhea and flushing episodes associated with metastatic carcinoid tumors | 1988 |
| Profuse watery diarrhea associated with vasoactive intestinal peptide (VIP)-secreting tumors | |||
| Oprelvekin | Neumega (Genetics Institute) | Prevention of severe thrombocytopenia and the reduction of the need for platelet transfusions following myelosuppressive chemotherapy in patients with nonmyeloid malignancies who are at high risk of severe thrombocytopenia | 1997 |
| Oxymetholone | Anadrol-50 (Unimed) | Myelofibrosis, hypoplastic anemias owing to the administration of myelotoxic drugs | 1960 |
| Pegaspargase | Oncaspar (Enzon) | Patients with acute lymphoblastic leukemia who require L-asparaginase in their treatment regimen but have developed hypersensitivity to the native forms of L-asparaginase | 1994 |
| Pentostatin | Nipent (SuperGen) | Single-agent treatment for both untreated and alpha-interferon-refractory hairy cell leukemia patients with active disease as defined by clinically significant anemia, neutropenia, thrombocytopenia, or disease-related symptoms | 1991 |
| Plicamycin | Mithracin (Bayer) | Hospitalized patients with malignant tumors of the testis in whom successful treatment by surgery and/or radiation is impossible | 1970 |
| Hypercalcemia and hypercalciuria associated with a variety of advanced neoplasms | |||
| Polifeprosan 20/carmustine | Gliadel (Aventis) | Adjunct to surgery to prolong survival in patients with recurrent glioblastoma multiforme for whom surgical resection is indicated | 1996 |
| Porfimer sodium | Photofrin (Axcan Scandipharm) | Palliation of patients with completely obstructing esophageal cancer or of patients with partially obstructing esophageal cancer who, in the opinion of their physician, cannot be satisfactorily treated with Nd:YAG laser therapy | 1995 |
| Reduction of obstruction and palliation of symptoms in patients with completely or partially obstructing endobronchial non-small-cell lung cancer (NSCLC) | |||
| Microinvasive endobronchial NSCLC in patients for whom surgery and radiotherapy are not indicated | |||
| Prednisolone | Prelone (Muro) | Hypercalcemia associated with cancer, mycosis fungoides, idiopathic thrombocytopenic purpura in adults, secondary thrombocytopenia in adults, erythroblastopenia, palliative management of leukemias and lymphomas in adults, palliative management of acute leukemia of childhood | 1955 |
| Prednisone | Deltasone (Pharmacia) | Hypercalcemia associated with cancer, mycosis fungoides, idiopathic thrombocytopenic purpura in adults, secondary thrombocytopenia in adults, erythroblastopenia, palliative management of leukemias and lymphomas in adults, palliative management of acute leukemia of childhood | 1955 |
| (Multiple myeloma- see carmustine) | |||
| Procarbazine | Matulane (Sigma-Tau) | Combination with other anticancer drugs for the treatment of stage III and IV Hodgkin's disease. | 1969 |
| Matulane is used as part of the MOPP (nitrogen mustard, vincristine, procarbazine, prednisone) regimen | |||
| Progesterone | Prometrium (Solvay) | Prevention of endometrial hyperplasia in non-hysterectomized postmenopausal women who are receiving conjugated estrogen tablets | 1939 |
| Rituximab | Rituxan (Genentech, IDEC) | Relapsed or refractory low grade or follicular, CD20 positive, B-cell non-Hodgkin's lymphoma | 1997 |
| Samarium-153 lexidronam pentasodium | Quadramet (Berlex) | Relief of pain in patients with confirmed osteoblastic metastatic bone lesions that enhance on radionuclide bone scan | 1997 |
| Sodium iodide I-131 | Iodotope (Bracco) | Carcinoma of the thyroid | 1957 |
| Sodium Iodide I-131 (CIS-US, Mallinckrodt) | |||
| Sodium phosphate P-32 | Sodium Phosphate P-32 (Mallinckrodt) | Polycythemia vera, chronic myelocytic leukemia, chronic lymphocytic leukemia, and palliative treatment of selected patients with multiple areas of skeletal metastases | 1952 |
| Streptozocin | Zanosar (Pharmacia) | Metastatic islet cell carcinoma of the pancreas | 1982 |
| Strontium-89 chloride | Metastron (Nycomed Amersham) | Relief of bone pain in patients with painful skeletal metastases | 1993 |
| Talc | Sclerosol (Bryan) | Prevention of recurrence of malignant pleural effusions in symptomatic patients | 1997 |
| Tamoxifen citrate | Nolvadex (AstraZeneca) | Metastatic breast cancer: tamoxifen is effective in the treatment of metastatic breast cancer in women and men; in premenopausal women with metastatic breast cancer, tamoxifen is an alternative to oophorectomy or ovarian irradiation; available evidence indicates that patients whose tumors are estrogen receptor positive are more likely to benefit from tamoxifen therapy | 1977 |
| Adjuvant treatment of breast cancer: tamoxifen is indicated for the treatment of node-positive breast cancer in postmenopausal women following total mastectomy or segmental mastectomy, axillary dissection, and breast irradiation; tamoxifen is indicated for the treatment of axillary node-negative breast cancer in women following total mastectomy or segmental mastectomy, axillary dissection, and breast irradiation | |||
| Ductal carcinoma in situ (DCIS): in women with DCIS, following breast surgery and radiation, tamoxifen Ductal carcinoma in situ (DCIS): in women with DCIS, following breast surgery and radiation, tamoxifen | |||
| Reduction in breast cancer incidence in high-risk women: tamoxifen is indicated to reduce the incidence of breast cancer in women at high risk for breast cancer | |||
| Temozolomide | Temodar (Schering) | Adult patients with refractory anaplastic astrocytoma, ie, patients at first relapse who have experienced disease progression on a drug regimen containing a nitrosourea and procarbazine | 1999 |
| Teniposide | Vumon (Bristol-Myers Squibb) | Combination with other approved anticancer agents for induction therapy in patients with refractory childhood acute lymphoblastic leukemia | 1992 |
| Testolactone | Teslac (Bristol-Myers Squibb) | Adjunctive therapy in the palliative treatment of advanced or disseminated breast cancer in postmenopausal women when hormonal therapy is indicated; it may also be used in women who were diagnosed as having had disseminated breast carcinoma when premenopausal, in whom ovarian function has been subsequently terminated | 1970 |
| Testosterone enanthate | Delatestryl (Bio-Technology General) | Secondarily in women with advancing inoperable metastatic (skeletal) mammary cancer who are 1 to 5 yr postmenopausal | 1939 |
| Thioguanine | Tabloid (GlaxoSmithKline) | Remission induction, remission consolidation, and maintenance therapy of acute nonlymphocytic leukemias; although thioguanine is one of several agents with activity in the treatment of the chronic phase of chronic myelogenous leukemia, more objective responses are observed with busulfan, and therefore busulfan is usually regarded as the preferred drug | 1966 |
| Thiotepa | Thioplex (Immunex) | Adenocarcinoma of the breast and ovary | 1959 |
| Intracavitary effusions secondary to diffuse or localized neoplastic diseases of various serosal cavities | |||
| Superficial papillary carcinoma of the urinary bladder | |||
| Although now largely superseded by other treatments, thiotepa has been effective against other lymphomas, such as lymphosarcoma and Hodgkin's disease | |||
| Topotecan | Hycamtin (GlaxoSmithKline) | Metastatic carcinoma of the ovary after failure of initial or subsequent chemotherapy | 1996 |
| Small-cell lung cancer-sensitive disease after failure of first-line chemotherapy | |||
| Toremifene citrate | Fareston (Schering) | Metastatic breast cancer in postmenopausal women with estrogen-receptor positive or unknown tumors | 1997 |
| Trastuzumab | Herceptin (Genentech) | Single agent for the treatment of patients with metastatic breast cancer whose tumors overexpress the HER-2 protein and who have received one or more chemotherapy regimens for their metastatic disease, combination with paclitaxel for treatment of patients with metastatic breast cancer whose tumors overexpress the HER-2 protein and who have not received chemotherapy for their metastatic disease | 1998 |
| Tretinoin | Vesanoid (Roche) | Induction of remission in patients with acute promyelocytic leukemia, French-American-British classification M3 (including the M3 variant), characterized by the presence of the t(15;17) translocation and/or the presence of the PML/RARα gene who are refractory to, or who have relapsed from, anthracycline chemotherapy or for whom anthracycline-based chemotherapy is contraindicated | 1971 |
| Triamcinolone | Aristocort (Fujisawa) | Hypercalcemia associated with cancer, mycosis fungoides, idiopathic thrombocytopenic purpura in adults, secondary thrombocytopenia in adults, erythroblastopenia, palliative management of leukemias and lymphomas in adults, palliative management of acute leukemia of childhood | 1957 |
| Triptorelin pamoate | Trelstar Depot (Pharmacia) | Palliative treatment of advanced prostate cancer | 2000 |
| Valrubicin | Valstar (Medeva) | Intravesical therapy of BCG-refractory carcinoma in situ of the urinary bladder in patients for whom immediate cystectomy would be associated with unacceptable morbidity or mortality | 1998 |
| Vinblastine | Velban (Eli Lilly) | Palliative treatment of: frequently responsive malignancies: generalized Hodgkin's disease (stages III and IV, Ann Arbor modification of Rye staging system), lymphocytic lymphoma (nodular and diffuse, poorly and well differentiated), histiocytic lymphoma, mycosis fungoides (advanced stages), advanced carcinoma of the testis, Kaposi sarcoma, Letterer-Siwe disease (histiocytosis X) | 1961 |
| Less frequently responsive malignancies: choriocarcinoma resistant to other chemotherapeutic agents, carcinoma of the breast unresponsive to appropriate endocrine surgery and hormonal therapy | |||
| Vincristine | Oncovin (Eli Lilly) | Acute leukemia | 1963 |
| Vincasar (Pharmacia) | Combination with other oncolytic agents in Hodgkin's disease, non-Hodgkin's malignant lymphomas (lymphocytic, mixed cell, histiocytic, undifferentiated, nodular, and diffuse types), rhabdomyosarcoma, neuroblastoma, and Wilms tumor | ||
| Vinorelbine | Navelbine (GlaxoSmithKline) | Single agent or in combination with cisplatin for the first-line treatment of ambulatory patients with unresectable, advanced NSCLC; in patients with stage IV NSCLC, Navelbine is indicated as a single agent or in combination with cisplatin; in stage III NSCLC, Navelbine is indicated in combination with cisplatin | 1994 |
Please refer to approved product labels for exact language regarding the approved indications.
Date first FDA approval was received (any indication).
- Table 45-1, FDA-Approved Anticancer Agents and Their Indications a - Holland-Fre...Table 45-1, FDA-Approved Anticancer Agents and Their Indications a - Holland-Frei Cancer Medicine
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