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Brand NameTrade NameFDA Approval ForLink

A

Adriamycindoxorubicin Doxil (doxorubicin HCl liposome injection) is indicated for: The treatment of metastatic carcinoma of the ovary in patients with disease that is refractory to both paclitaxel- and platinum-based chemotherapy regimens. Refractory disease is defined as disease that has progressed while on treatment, or within 6 months of completing treatment. The treatment of AIDS-related Kaposi’s sarcoma in patients with disease that has progressed on prior combination chemotherapy or in patients who are intolerant to such therapy. These indications are based on objective tumor response rates. No results are available from controlled trials that demonstrate a clinical benefit resulting from this treatment, such as improvement in disease-related symptoms or increased survival. Link
Adrucil fluorouracil, 5-FU ADRUCIL Injection is effective in the palliative management of carcinoma of the colon, rectum, breast, stomach and pancreas. Link
Alkeran melphalan, L-PAMALKERAN Tablets are indicated for the palliative treatment of multiple myeloma and for the palliation of non-resectable epithelial carcinoma of the ovary.Link
Arimidex anastrozole Treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy and first-line treatment of postmenopausal women with hormone receptor positive or hormone receptor unknown locally advanced or metastatic breast cancer.Link

B

BCNU, BiCNU carmustine BiCNU is indicated as palliative therapy as a single agent or in established combination therapy with other approved chemotherapeutic agents in the following: 1. Brain tumors— glioblastoma, brainstem glioma, medulloblastoma, astrocytoma, ependymoma, and metastatic brain tumors. 2. Multiple myeloma— in combination with prednisone. 3. 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. 4. 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. Link
Blenoxane bleomycin sulfateBLENOXANE should be considered a palliative treatment. It has been shown to be useful in the management of the following neoplasms either as a single agent or in proven combinations with other approved chemotherapeutic agents: Squamous Cell Carcinoma Head and neck (including mouth, tongue, tonsil, nasopharynx, oropharynx, sinus, palate, lip, buccal mucosa, gingivae, epiglottis, skin, larynx), penis, cervix, and vulva. The response to BLENOXANE is poorer in patients with previously irradiated head and neck cancer. Lymphomas Hodgkin's Disease, non-Hodgkin's lymphoma. Testicular Carcinoma Embryonal cell, choriocarcinoma, and teratocarcinoma. BLENOXANE has also been shown to be useful in the management of: Malignant Pleural Effusion BLENOXANE is effective as a sclerosing agent for the treatment of malignant pleural effusion and prevention of recurrent pleural effusions.Link
Busulfex busulfan intravenousBUSULFEX (busulfan) Injection is indicated for use in combination with cyclophosphamide as a conditioning regimen prior to allogeneic hematopoietic progenitor cell transplantation for chronic myelogenous leukemia. Link

C

Camptosar irinotecan CAMPTOSAR Injection is indicated for the treatment of patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following 5-FU-based therapy. Link
CeeBU lomustine, CCNU CeeNU has been shown to be useful as a single agent in addition to other treatment modalities, or in established combination therapy with other approved chemotherapeutic agents in the following: 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. Link
Cytoxancyclophosphamide Malignant Diseases CYTOXAN, although effective alone in susceptible malignancies, is more frequently used concurrently or sequentially with other antineoplastic drugs. The following malignancies are often susceptible to CYTOXAN treatment: 1. 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’s lymphoma. 2. Multiple myeloma. 3. 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 (CYTOXAN given during remission is effective in prolonging its duration). 4. Mycosis fungoides (advanced disease). 5. Neuroblastoma (disseminated disease). 6. Adenocarcinoma of the ovary. 7. Retinoblastoma. 8. Carcinoma of the breast. Nonmalignant Disease Biopsy Proven “MinimalChange” Nephrotic Syndrome in Children CYTOXAN is useful in carefully selected cases of biopsy proven “minimal change” nephrotic syndrome in children but should not be used as primary therapy. In children whose disease fails to respond adequately to appropriate adrenocorticosteroid therapy or in whom the adrenocorticosteroid therapy produces or threatens to produce intolerable side effects, CYTOXAN may induce a remission. CYTOXAN is not indicated for the nephrotic syndrome in adults or for any other renal disease. Link

D

Doxil doxorubicin liposomal 1. The treatment of metastatic carcinoma of the ovary in patients with disease that is refractory to both paclitaxel- and platinum-based chemotherapy regimens. Refractory disease is defined as disease that has progressed while on treatment, or within 6 months of completing treatment. 2. The treatment of AIDS-related Kaposi’s sarcoma in patients with disease that has progressed on prior combination chemotherapy or in patients who are intolerant to such therapy. These indications are based on objective tumor response rates. No results are available from controlled trials that demonstrate a clinical benefit resulting from this treatment, such as improvement in disease-related symptoms or increased survival.Link
DTIC-Domedacarbazine DTIC-Dome is indicated in the treatment of metastatic malignant melanoma. In addition, DTIC-Dome is also indicated for Hodgkin's disease as a secondary-line therapy when used in combination with other effective agents. Link

E

Eloxatin oxaliplatin ELOXATIN, used in combination with infusional 5-FU/LV, is indicated for the treatment of patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed during or within 6 months of completion of first line therapy with the combination of bolus 5-FU/LV and irinotecan. The approval of ELOXATIN is based on response rate and an interim analysis showing improved time to radiographic progression. No results are available at this time that demonstrate a clinical benefit, such as improvement of disease-related symptoms or increased survival (see CLINICAL STUDIES). Link
Emcyt estramustine EMCYT Capsules are indicated in the palliative treatment of patients with metastatic and/or progressive carcinoma of the prostate. Link
Ergamisol levamisole ERGAMISOL (levamisole hydrochloride) is only indicated as adjuvant treatment in combination with fluorouracil after surgical resection in patients with Dukes' stage C colon cancer. Link

F

Fareston toremifene FARESTON is indicated for the treatment of metastatic breast cancer in postmenopausal women with estrogen-receptor positive or unknown tumors. Link
Faslodex fulvestrant FASLODEX is indicated for the treatment of hormone receptor positive metastatic breast cancer in postmenopausal women with disease progression following antiestrogen therapy. Link
Femara letrozole Femara (letrozole tablets) is indicated for the treatment of advanced breast cancer in postmenopausal women with disease progression following antiestrogen therapy. Link
FUDR floxuridine (intraarterial) FUDR is effective in the 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. Patients with known disease extending beyond an area capable of infusion via a single artery should, except in unusual circumstances, be considered for systemic therapy with other chemotherapeutic agents. Link

G

Gemzar gemcitabine Therapeutic Indications Non-Small Cell Lung Cancer -Gemzar is indicated in 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. Pancreatic Cancer -Gemzar is indicated as 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. Link
Gleevec imatinib mesylate Gleevec (imatinib mesylate) is indicated for the treatment of patients with chronic myeloid leukemia (CML) in blast crisis, accelerated phase, or in chronic phase after failure of interferon-alpha therapy. The effectiveness of Gleevec is based on overall hematologic and cytogenetic response rates (see CLINICAL PHARMACOLOGY: CLINICAL STUDIES). There are no controlled trials demonstrating a clinical benefit, such as improvement in disease-related symptoms or increased survival. Link
Gliadel Wafer carmustine with Polifeprosan 20 Implant GLIADEL® Wafer is indicated in newly-diagnosed high-grade malignant glioma patients as an adjunct to surgery and radiation. GLIADEL®Wafer is indicated in recurrent glioblastoma multiforme patients as an adjunct to surgery.Link

H

Herceptin trastuzumabHERCEPTIN as a single agent is indicated for the treatment of patients with metastatic breast cancer whose tumors overexpress the HER2 protein and who have received one or more chemotherapy regimens for their metastatic disease. HERCEPTIN in combination with paclitaxel is indicated for treatment of patients with metastatic breast cancer whose tumors overexpress the HER2 protein and who have not received chemotherapy for their metastatic disease. HERCEPTIN should only be used in patients whose tumors have HER2 protein overexpression. (See CLINICAL STUDIES: HER2 protein overexpression for information regarding HER2 protein testing and the relationship between the degree of overexpression and the treatment effect.) Link
Hycamtin topotecan Hycamtin is indicated for the treatment of: metastatic carcinoma of the ovary after failure of initial or subsequent chemotherapy. small cell lung cancer sensitive disease after failure of first-line chemotherapy. In clinical studies submitted to support approval, sensitive disease was defined as disease responding to chemotherapy but subsequently progressing at least 60 days (in the phase 3 study) or at least 90 days (in the phase 2 studies) after chemotherapyLink

I

Idamycin idarubicin IDAMYCIN PFS Injection in combination with other approved antileukemic drugs is indicated for the treatment of acute myeloid leukemia (AML) in adults. This includes French-American-British (FAB) classifications M1 through M7. Link
IFEX ifosfamide IFEX, used in combination with certain other approved antineoplastic agents, is indicated 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. Link

L

Leucovorin Leucovorin Leucovorin calcium rescue is indicated after high­dose methotrexate therapy in osteosarcoma. Leucovorin is also indicated to diminish the toxicity and counteract the effects of impaired methotrexate elimination and of inadvertent overdosages of folic acid antagonists. Link

M

Matulaneprocarbazine Matulane is indicated for use in combination with other anticancer drugs for the treatment of Stage III and IV Hodgkin's disease. Matulane is used as part of the MOPP (nitrogen mustard, vincristine, procarbazine, prednisone) regimen. Link
Methotrexate methotrexate Neoplastic Diseases Methotrexate is indicated in the treatment of gestational choriocarcinoma, chorioadenoma destruens and hydatidiform mole. 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 non-metastatic osteosarcoma who have undergone surgical resection or amputation for the primary tumor. (Methotrexate is also indicated for other non-oncologic diagnoses).Link
Mitozytrex mitomycin C Mitomycin for Injection is not recommended as single-agent, primary therapy. It has been shown to be useful in the therapy of disseminated adenocarcinoma of the stomach or pancreas in proven combinations with other approved chemotherapeutic agents and as palliative treatment when other modalities have failed. Mitomycin is not recommended to replace appropriate surgery and/or radiotherapy. Link

N

Navelbine vinorelbine NAVELBINE is indicated as a single-agent or in combination with cisplatin for the first-line treatment of ambulatory patients with unresectable, advanced nonsmall cell lung cancer 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. Link
Nolvadex tamoxifen Metastatic Breast Cancer: Tamoxifen citrate is effective in the treatment of metastatic breast cancer in women and men… Adjuvant Treatment of Breast Cancer: Tamoxifen citrate 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 citrate is indicated for the treatment of axillary node-negative breast cancer in women following total mastectomy or segmental mastectomy, axillary dissection, and breast irradiation…Tamoxifen citrate is indicated to reduce the incidence of breast cancer in women at high risk for breast cancer…Tamoxifen citrate is indicated for high-risk women. "High risk" is defined as women at least 35 years of age with a 5-year predicted risk of breast cancer ³1.67%, as calculated by the Gail Model. Link

O

Oncovin vincristine Vincristine sulfate injection is indicated in acute leukemia. Vincristine sulfate injection has also been shown to be useful in 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.Link

P

ParaplatincarboplatinLink
Paraplatin carboplatin Initial treatment of advanced ovarian carcinoma: PARAPLATIN is indicated for the initial treatment of advanced ovarian carcinoma in established combination with other approved chemotherapeutic agents. One established combination regimen consists of PARAPLATIN and cyclophosphamide (CYTOXAN )… Secondary treatment of advanced ovarian carcinoma: PARAPLATIN is indicated for the palliative treatment of patients with ovarian carcinoma recurrent after prior chemotherapy, including patients who have been previously treated with cisplatin. Within the group of patients previously treated with cisplatin, those who have developed progressive disease while receiving cisplatin therapy may have a decreased response rate.Link
PemetrexedalimtaALIMTA in combination with cisplatin is indicated for the treatment of patients with malignant pleural mesothelioma whose disease is either unresectable or who are otherwise not candidates for curative surgery.Link
Platinol cisplatin PLATINOL-AQ (cisplatin injection) is indicated as therapy to be employed as follows: 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. 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. An established combination consists of PLATINOL-AQ and CYTOXAN (cyclophosphamide). PLATINOL-AQ, as a single agent, is indicated as secondary therapy in patients with metastatic ovarian tumors refractory to standard chemotherapy who have not previously received PLATINOL-AQ therapy. Advanced Bladder Cancer: PLATINOL-AQ is indicated as a single agent for patients with transitional cell bladder cancer which is no longer amenable to local treatments such as surgery and/or radiotherapy. Link
ProleukinAldesleukin Adults with metastatic renal cell carcinoma (metastatic RCC). PROLEUKIN is indicated for the treatment of adults with metastatic melanoma.

R

RaltitrexedtomudexNot FDA ApprovedLink
RanpirnaseonconaseNot FDA Approved. Link goes to company's press release of Oct. 14, 2004. Link

T

Taxol paclitaxel TAXOL is indicated, after failure of first-line or subsequent chemotherapy for the treatment of metastatic carcinoma of the ovary. TAXOL is indicated for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated. TAXOL is indicated for the second-line treatment of AIDS-related Kaposi’s sarcoma. Link
Taxotere docetaxel Breast Cancer: TAXOTERE (docetaxel) for Injection Concentrate is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of prior chemotherapy. Non-Small Cell Lung Cancer: TAXOTERE (docetaxel) for Injection Concentrate is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of prior platinum-based chemotherapy. Link
Temodar temozolomide TEMODAR (temozolomide) Capsules are indicated for the treatment of adult patients with refractory anaplastic astrocytoma, i.e., patients at first relapse who have experienced disease progression on a drug regimen containing a nitrosourea and procarbazine. This indication is based on the response rate in the indicated population. No results are available from randomized controlled trials in recurrent anaplastic astrocytoma that demonstrate a clinical benefit resulting from treatment, such as improvement in disease- related symptoms, delayed disease progression, or improved survival. Link
ThalomidthalidomideTHALOMID® (thalidomide) is indicated erythema nodosum leprosum (ENL). THALOMID® (thalidomide) is not indicated severe neuritis. THALOMID® (thalidomide) is also indicated manifestations of ENL recurrence.Link
Thioplex thiotepa Thiotepa has been tried with varying results in the palliation of a wide variety of neoplastic diseases. However, the most consistent results have been seen in the following tumors: 1. Adenocarcinoma of the breast. 2. Adenocarcinoma of the ovary. 3. For controlling intracavitary effusions secondary to diffuse or localized neoplastic diseases of various serosal cavities. 4. For the treatment of superficial papillary carcinoma of the urinary bladder. While now largely superseded by other treatments, thiotepa has been effective against other lymphomas, such as lymphosarcoma and Hodgkin's disease. Link
Trisenox arsenic trioxide Second line treatment of relapsed or refractory APL following ATRA plus an anthracycline. Link

V

Vepesid etoposide, VP-16 VePesid (etoposide) is indicated in the management of the following neoplasms: Refractory Testicular Tumors: VePesid For Injection in combination therapy with other approved chemotherapeutic agents in patients with refractory testicular tumors who have already received appropriate surgical, chemotherapeutic, and radiotherapeutic therapy. Adequate data on the use of VePesid Capsules in the treatment of testicular cancer are not available. Small Cell Lung Cancer: VePesid For Injection and/or Capsules in combination with other approved chemotherapeutic agents as first line treatment in patients with small cell lung cancer. Link
Vumon teniposide, VM-26 VUMON, in combination with other approved anticancer agents, is indicated for induction therapy in patients with refractory childhood acute lymphoblastic leukemia. Link

X

Xeloda capecitabine XELODA is indicated for the treatment of patients with 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, e.g., patients who have received cumulative doses of 400 mg/m2 of doxorubicin or doxorubicin equivalents. Resistance is defined as progressive disease while on treatment, with or without an initial response, or relapse within 6 months of completing treatment with an anthracycline-containing adjuvant regimen. This indication is based on demonstration of a response rate. No results are available from controlled trials that demonstrate a clinical benefit resulting from treatment, such as improvement in diseaserelated symptoms, disease progression, or survival. Link