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

Table 2.

Known drugs that received new oncology indications by the United States FDA in 2000 to 2009

Drug Year Original indication New indication
Imatinib mesylate (Gleevec) 2002 Treatment of chronic myelogenous leukemia Treatment of patients with KIT (CD117) positive unresectable and/or metastatic malignant GISTs
Gemcitabine hydrochloride (Gemzar) 2004 Treatment of lung cancer 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
Docetaxel 2004 Treatment of breast cancer Combination with prednisone as a treatment for patients with androgen-independent (hormone refractory) metastatic prostate cancer
Bortezomib (Velcade) 2006 Treatment of multiple myeloma Treatment of patients with mantle cell lymphoma who have received at least 1 prior therapy
Imatinib mesylate (Gleevec) 2006 Treatment of chronic myelogenous leukemia Treatment of adult myelodysplastic syndrome/myeloproliferative diseases
Treatment of adult Philadelphia chromosome-positive acute lymphoblastic leukemia monotherapy
Treatment of adult hypereosinophilic syndrome/chronic eosinophilic leukemia
Docetaxel (Taxotere) 2006 Treatment of breast cancer Combination with cisplatin and fluorouracil for the induction treatment of patients with inoperable locally advanced squamous cell carcinoma of the head and neck
Gemcitabine hydrochloride 2006 Treatment of lung cancer Combination with carboplatin for the treatment of patients with advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy
Lenalidomide (Revlimid) 2006 Treatment of myelodysplastic syndromes Combination with dexamethasone for the treatment of multiple myeloma patients who have received at least one prior therapy
Dasatinib (Sprycel) 2006 Treatment of chronic myelogenous leukemia Treatment of patients with Philadelphia chromosome-positive acute lymphoblastic leukemia with resistance or intolerance to prior therapy
Thalidomide (Thalomid) 2006 Sedative treatment and prevention of the cutaneous manifestations of moderate to severe erythema nodosum leprosum Treatment of patients with newly diagnosed multiple myeloma
Raloxifene hydrochloride 2007 Prevention of osteoporosis Reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis and reduction in risk of invasive breast cancer in postmenopausal women at high risk for invasive breast cancer

No compounds were approved in 2000, 2001, 2003, 2005, 2008, or 2009 for new oncology indications. Data are adapted from the Efficacy Supplement Approvals page of the United States FDA (www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/DrugandBiologicApprovalReports/EfficacySupplementApprovals/default.htm) and the Drugs@FDA database.