New drugs approved by the United States FDA for oncology indications, 2000 to 2009
| Drug . | Year . | Indication . |
|---|---|---|
| Gemtuzamab ozogamycin (Mylotarg)* | 2000 | Treatment of CD33+ AML patients in first relapse, > 60 years of age, and not considered candidates for cytotoxic chemotherapy |
| Arsenic trioxide (Trisenox) | 2000 | Induction of remission and consolidation in patients with acute promyelocytic leukemia, who are refractory to or have relapsed from retinoid and anthracycline chemotherapy and whose disease is characterized by the presence of the t(15;17) translocation or promyelocytic leukemia-retinoic acid receptor-α gene expression |
| Imatinib mesylate (Gleevec) | 2001 | Treatment of patients with chronic myeloid leukemia in blast crisis, accelerated phase or chronic phase, after failure of interferon-α therapy |
| Fulvestrant (Faslodex) | 2002 | Treatment of hormone receptor-positive metastatic breast cancer in postmenopausal women with disease progression after antiestrogen therapy |
| Oxaliplatin (Eloxatin) | 2002 | Indicated in combination with infusional 5-fluorouracil/leucovorin for 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 |
| Gefitinib (Iressa) | 2003 | Treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of both platinum-based and docetaxel chemotherapies |
| Bortezomib (Velcade) | 2003 | Treatment of multiple myeloma patients who have received at least 2 prior therapies and have demonstrated disease progression on the last therapy |
| Azacitidine (Vidaza) | 2004 | Treatment of patients with myelodysplastic syndrome subtypes: refractory anemia or refractory anemia with ringed sideroblasts (if accompanied by neutropenia or thrombocytopenia and requiring transfusions); refractory anemia with excess blasts; refractory anemia with excess blasts in transformation; and chronic myelomonocytic leukemia |
| Erlotinib hydrochloride (Tarceva) | 2004 | Treatment of locally advanced or metastatic non-small cell lung cancer after failure of at least one prior chemotherapy regimen |
| Nelarabine (Arranon) | 2005 | Treatment of patients with T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma whose disease has not responded to or has relapsed after treatment with at least 2 chemotherapy regimens |
| Sorafenib tosylate (Nexavar) | 2005 | Treatment of patients with advanced renal cell carcinoma |
| Lenalidomide (Revlimid) | 2005 | Treatment of patients with transfusion-dependent anemia resulting from low or intermediate-1 risk myelodysplastic syndromes associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities |
| Sunitinib malate (Sutent) | 2006 | Treatment of GIST after disease progression on, or intolerance to, imatinib mesylate |
| Decitabine (Dacogen) | 2006 | Treatment of myelodysplastic syndrome |
| Dasatinib (Sprycel) | 2006 | Treatment of adults with chronic myeloid leukemia with resistance or intolerance to prior therapy, including imatinib |
| Vorinostat (Zolinza) | 2006 | Treatment of cutaneous manifestations in patients with cutaneous T-cell lymphoma who have progressive, persistent, or recurrent disease on or after 2 systemic therapies |
| Lapatinib (Tykerb) | 2007 | Treatment of patients with advanced or metastatic breast cancer whose tumors overexpress HER2 (ErbB2) and who have received prior therapy, including anthracycline, a taxane, and trastuzumab |
| Temsirolimus (Torisel) | 2007 | Treatment of advanced renal cell carcinoma |
| Ixabepilone (Ixempra) | 2007 | In combination with capecitabine for the treatment of patients with metastatic or locally advanced breast cancer resistant to treatment with an anthracycline and a taxane, or whose cancer is taxane resistant and for whom further anthracycline therapy is contraindicated; the new drug also provides as monotherapy for the treatment of metastatic or locally advanced breast cancer in patients whose tumors are resistant or refractory to anthracyclines, taxanes, and capecitabine |
| Nirlotinib (Tasigna) | 2007 | Treatment of chronic phase and accelerated phase Philadelphia chromosome-positive chronic myelogenous leukemia in adult patients resistant to or intolerant to prior therapy that included Gleevec (imatinib) |
| Bendamustine hydrochloride (Treanda) | 2008 | Treatment of patients with chronic lymphocytic leukemia |
| Everolimus (Affinitor) | 2009 | Treatment of advanced renal cell carcinoma |
| Pralatrexate (Folotyn) | 2009 | Treatment of relapsed or refractory peripheral T-cell lymphoma |
| Pazopanib (Votrient) | 2009 | Treatment of advanced renal cell carcinoma |
| Romidepsin | 2009 | Treatment of cutaneous T-cell lymphoma in patients who have received at least one prior systemic therapy |
| Drug . | Year . | Indication . |
|---|---|---|
| Gemtuzamab ozogamycin (Mylotarg)* | 2000 | Treatment of CD33+ AML patients in first relapse, > 60 years of age, and not considered candidates for cytotoxic chemotherapy |
| Arsenic trioxide (Trisenox) | 2000 | Induction of remission and consolidation in patients with acute promyelocytic leukemia, who are refractory to or have relapsed from retinoid and anthracycline chemotherapy and whose disease is characterized by the presence of the t(15;17) translocation or promyelocytic leukemia-retinoic acid receptor-α gene expression |
| Imatinib mesylate (Gleevec) | 2001 | Treatment of patients with chronic myeloid leukemia in blast crisis, accelerated phase or chronic phase, after failure of interferon-α therapy |
| Fulvestrant (Faslodex) | 2002 | Treatment of hormone receptor-positive metastatic breast cancer in postmenopausal women with disease progression after antiestrogen therapy |
| Oxaliplatin (Eloxatin) | 2002 | Indicated in combination with infusional 5-fluorouracil/leucovorin for 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 |
| Gefitinib (Iressa) | 2003 | Treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of both platinum-based and docetaxel chemotherapies |
| Bortezomib (Velcade) | 2003 | Treatment of multiple myeloma patients who have received at least 2 prior therapies and have demonstrated disease progression on the last therapy |
| Azacitidine (Vidaza) | 2004 | Treatment of patients with myelodysplastic syndrome subtypes: refractory anemia or refractory anemia with ringed sideroblasts (if accompanied by neutropenia or thrombocytopenia and requiring transfusions); refractory anemia with excess blasts; refractory anemia with excess blasts in transformation; and chronic myelomonocytic leukemia |
| Erlotinib hydrochloride (Tarceva) | 2004 | Treatment of locally advanced or metastatic non-small cell lung cancer after failure of at least one prior chemotherapy regimen |
| Nelarabine (Arranon) | 2005 | Treatment of patients with T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma whose disease has not responded to or has relapsed after treatment with at least 2 chemotherapy regimens |
| Sorafenib tosylate (Nexavar) | 2005 | Treatment of patients with advanced renal cell carcinoma |
| Lenalidomide (Revlimid) | 2005 | Treatment of patients with transfusion-dependent anemia resulting from low or intermediate-1 risk myelodysplastic syndromes associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities |
| Sunitinib malate (Sutent) | 2006 | Treatment of GIST after disease progression on, or intolerance to, imatinib mesylate |
| Decitabine (Dacogen) | 2006 | Treatment of myelodysplastic syndrome |
| Dasatinib (Sprycel) | 2006 | Treatment of adults with chronic myeloid leukemia with resistance or intolerance to prior therapy, including imatinib |
| Vorinostat (Zolinza) | 2006 | Treatment of cutaneous manifestations in patients with cutaneous T-cell lymphoma who have progressive, persistent, or recurrent disease on or after 2 systemic therapies |
| Lapatinib (Tykerb) | 2007 | Treatment of patients with advanced or metastatic breast cancer whose tumors overexpress HER2 (ErbB2) and who have received prior therapy, including anthracycline, a taxane, and trastuzumab |
| Temsirolimus (Torisel) | 2007 | Treatment of advanced renal cell carcinoma |
| Ixabepilone (Ixempra) | 2007 | In combination with capecitabine for the treatment of patients with metastatic or locally advanced breast cancer resistant to treatment with an anthracycline and a taxane, or whose cancer is taxane resistant and for whom further anthracycline therapy is contraindicated; the new drug also provides as monotherapy for the treatment of metastatic or locally advanced breast cancer in patients whose tumors are resistant or refractory to anthracyclines, taxanes, and capecitabine |
| Nirlotinib (Tasigna) | 2007 | Treatment of chronic phase and accelerated phase Philadelphia chromosome-positive chronic myelogenous leukemia in adult patients resistant to or intolerant to prior therapy that included Gleevec (imatinib) |
| Bendamustine hydrochloride (Treanda) | 2008 | Treatment of patients with chronic lymphocytic leukemia |
| Everolimus (Affinitor) | 2009 | Treatment of advanced renal cell carcinoma |
| Pralatrexate (Folotyn) | 2009 | Treatment of relapsed or refractory peripheral T-cell lymphoma |
| Pazopanib (Votrient) | 2009 | Treatment of advanced renal cell carcinoma |
| Romidepsin | 2009 | Treatment of cutaneous T-cell lymphoma in patients who have received at least one prior systemic therapy |
Data are adapted from the United States FDA New Molecular Entities (NME) approvals database (www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/DrugandBiologicApprovalReports/ucm121136.htm).
This drug's approval was rescinded in 2010 because of toxicity.