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. 2011 Apr 21;117(25):6747–6755. doi: 10.1182/blood-2011-02-315283

Table 1.

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

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.