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.