List of U.S. FDA Approved Oncology Drugs with Approved Indications
| Generic Drug | Drug Trade Name | Approved Use | Manufacturer/ Distributor | Approval Date |
|---|---|---|---|---|
| anastrozole | Arimidex | Treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy. | AstraZeneca Pharmaceuticals | 1995 |
| anastrozole | Arimidex | For first-line treatment of postmenopausal women with hormone receptor positive or hormone receptor unknown locally advanced or metastatic breast cancer. | AstraZeneca Pharmaceuticals | 2000 |
| bevacizumab | Avastin | Granted accelerated approval for use in combination with paclitaxel for the treatment of patients who have not received chemotherapy for metastatic HER2 negative breast cancer. | Genentech | 2008 |
| bleomycin | Blenoxane | Sclerosing agent for the treatment of malignant pleural effusion (MPE) and prevention of recurrent pleural effusions. | Bristol-Myers Squibb Company | 1996 |
| capecitabine | Xeloda | Accel. Approv. (clinical benefit subsequently established) Treatment of metastatic breast cancer resistant to both paclitaxel and an anthracycline containing chemotherapy regimen or resistant to paclitaxel and for whom further anthracycline therapy may be contraindicated, e.g., patients who have received cumulative doses of 400 mg/m2 of doxorubicin or doxorubicin equivalents | Roche | 1998 |
| capecitabine | Xeloda | Conversion to regular approval for treatment in combination with docetaxel of patients with metastatic breast cancer after failure of prior anthracycline containing chemotherapy | Roche | 2001 |
| cyclophosphamide | Cytoxan Injection and Cytoxan Tablet | For Carcinoma of the breast | Bristol-Myers Squibb Company | 1987 |
| dalteparin sodium | Fragmin | Provides for the use of Fragmin (dalteparin sodium injection) for extended treatment of symptomatic venous thromboembolism (VTE) [proximal deep vein thrombosis (DVT) and/or pulmonary embolism (PE)] to reduce the recurrence of VTE in patients with cancer. | Pharmacia & Upjohn Pfizer |
2007 |
| Darbepoetin alfa** | Aranesp** | Aranesp is indicated for the treatment of anemia in patients with non- myeloid malignancies where anemia is due to the effect of concomitantly administered chemotherapy. | Amgen | 2002 |
| dexrazoxane | Zinecard | Accel. Approv. (clinical benefit subsequently established) Prevention of cardiomyopathy associated with doxorubicin administration | Pharmacia & Upjohn Now: Pfizer |
1995 |
| dexrazoxane | Zinecard | Conversion to regular approval for reducing the incidence and severity of cardiomyopathy associated with doxorubicin administration in women with metastatic breast cancer who have received a cumulative doxorubicin dose of 300 mg/m2 and who will continue to receive doxorubicin therapy to maintain tumor control. It is not recommended for use with the initiation of doxorubicin therapy. | Pharmacia & Upjohn Now: Pfizer |
2002 |
| docetaxel | Taxotere | Accel. Approv. (clinical benefit subsequently established) Treatment of patients with locally advanced or metastatic breast cancer who have progressed during anthracycline-based therapy or have relapsed during anthracycline-based adjuvant therapy. | Aventis Pharmaceutical Now:Sanofi-Aventis |
1996 |
| docetaxel | Taxotere | Conversion to regular approval - treatment of locally advanced or metastatic breast cancer which has progressed during anthracycline-based treatment or relapsed during anthracycline-based adjuvant therapy. | Aventis Pharmaceutical | 1998 |
| docetaxel | Taxotere | For use in combination with doxorubicin and cyclophosphamide for the adjuvant treatment of patients with operable node positive breast cancer | Aventis Pharmaceutical | 2004 |
| doxorubicin | Adriamycin PFS | For use in combination with cyclophosphamide as a component of adjuvant therapy in patients with evidence of axillary node tumor involvement following resection of primary breast cancer | Pharmacia & Upjohn Now: Pfizer |
2003 |
| doxorubicin | Adriamycin PFS Injection intravenous injection | Antibiotic, antitumor agent. | Pharmacia & Upjohn Now: Pfizer |
1987 |
| epirubicin | Ellence | A component of adjuvant therapy in patients with evidence of axillary node tumor involvement following resection of primary breast cancer. | Pharmacia & Upjohn Now: Pfizer |
1999 |
| epirubicin hcl | Epirubicin hcl | As a component of adjuvant therapy in patients with evidence of axillary node tumor involvement following resection of primary breast cancer. | Mayne Pharma Now: Hospira Link: http://www.hospira.com |
2006 |
| Epoetin alfa** | Epogen** /Procrit** | Indicated for the treatment of anemia associated with CRF, including patients on dialysis (ESRD) and patients not on dialysis. | Amgen J&J | 1999 |
| exemestane | Aromasin | For treatment of advance breast cancer in postmenopausal women whose disease has progressed following tamoxifen therapy. | Pharmacia & Upjohn Now: Pfizer |
1999 |
| fentanyl citrate | Fentora | For the management of breakthrough pain in patients with cancer who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain. | Cephalon | 2006 |
| Filgrastim | Neupogen | To reduce the duration of neutropenia and neutropenia-related clinical sequelae, e.g., febrile neutropenia, in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by marrow transplantation. | Amgen | 1998 |
| fluorouracil, 5-FU | Adrucil | Prolong survival in combination with leucovorin | ICN Pharmaceuticals, Inc. | 1962 |
| fulvestrant | Faslodex | For the treatment of hormone receptor-positive metastatic breast cancer in postmenopausal women with disease progression following antiestrogen therapy | AstraZeneca Pharmaceuticals | 2002 |
| gemicitabine | Gemzar | For use in combination with paclitaxel for the first-line treatment of patients with metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated | Eli Lilly and Company | 2004 |
| goserelin acetate | Zoladex Implant | Palliative treatment of advanced breast cancer in pre- and perimenopausal women. | AstraZeneca Pharmaceuticals | 1995 |
| ixabepilone | Ixempra | For 2 Indications:
|
Bristol-Myers Squibb Company | 2007 |
| lapatinib ditosylate | Tykerb | For use in combination with capecitabine for the treatment of patients with advanced or metastatic breast cancer whose tumors over express HER2 (ErbB2) and who have received prior therapy including an anthracycline, a taxane, and trastuzumab. |
SmithKline Beecham Now:GlaxoSmithKline |
2007 |
| letrozole | Femara | Treatment of advanced breast cancer in postmenopausal women. | Novartis | 1997 |
| letrozole | Femara | First-line treatment of postmenopausal women with hormone receptor positive or hormone receptor unknown locally advanced or metastatic breast cancer. | Novartis | 2001 |
| leucovorin calcium | Leucovorin | Used to prevent harmful effects of methotrexate and other cancer chemotherapy medications when used to treat breast cancer | Bedford Labratories | 1987 |
| megestrol acetate | Megace | Indicated for the palliative treatment of advanced carcinoma of the breast (i.e., recurrent, inoperable, or metastatic disease). It should not be used in lieu of currently accepted procedures such as surgery, radiation, or chemotherapy. | Bristol-Myers Squibb Company | 1971 |
| methotrexate | Methotrexate | Used in high doses alone or in combination with other chemotherapeutic agents in prolonging relapse-free survival in the treatment of breast cancer | Hospira, Inc. | 1953 |
| Oprelvekin | Neumega | Neumega is indicated for the prevention of severe thrombocytopenia and the reduction of the need for platelet transfusions following myelosuppressive chemotherapy in adult patients with nonmyeloid malignancies who are at high risk of severe thrombocytopenia. | Genetics Institute, Inc Now: Wyeth Pharmaceutical |
2002 |
| paclitaxel | Abraxane | 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. | Abraxis Bioscience, Inc. | 2007 |
| paclitaxel | Taxol | 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. | Bristol-Myers Squibb Company | 1994 |
| paclitaxel | Taxol | For the adjuvant treatment of node-positive breast cancer administered sequentially to standard doxorubicin-containing combination therapy. | Bristol-Myers Squibb Company | 1999 |
| paclitaxel protein-bound particles | Abraxane | 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 anthracyline unless clinically contraindicated | Abraxis Bioscience, Inc. | 2005 |
| Pegfilgrastim | Neulasta | Neulasta is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. | Amgen | 2002 |
| raloxifene hydrochloride | Evista | For reduction in the risk of invasive breast cancer in postmenopausal women with osteoporosis and in postmenopausal women at high risk for invasive breast cancer | Eli Lilly and Company | 2007 |
| talc | Sclerosol | For the prevention of the recurrence of malignant pleural effusion in symptomatic patients. | Bryan Corporation | 1997 |
| tamoxifen | Nolvadex | For use in premenopausal women with metastatic breast cancer as an alternative to oophorectomy or ovarian irradiation | AstraZeneca Pharmaceuticals | 1989 |
| tamoxifen | Nolvadex | Metastatic breast cancer in men. | AstraZeneca Pharmaceuticals | 1993 |
| tamoxifen | Nolvadex | to reduce the incidence of breast cancer in women at high risk for breast cancer | AstraZeneca Pharmaceuticals | 1998 |
| toremifene | Fareston | Treatment of advanced breast cancer in postmenopausal women. | Orion Corporation Now: GTx, Inc. |
1997 |
| Trastuzumab | Herceptin | Herceptin in combination with paclitaxel is indicated for treatment of patients with metastatic breast cancer whose tumors over express the HER-2 protein and had not received chemotherapy for their metastatic disease | Genentech | 2000 |
| Trastuzumab | Herceptin | Expanded use for early stage breast cancer after primary therapy. | Genentech | 2006 |
| zoledronic acid | Zometa | Treatment of hypercalcemia of malignancy | Novartis | 2001 |
** April 22, 2008, FDA notified the manufacturer of Epogen/Procrit and Aranesp of its decision to require additional safety-related changes to the labeling for these products. More information
