Cancer drugs and indications newly approved by the US Food and Drug Administration, May 2007 – February 2009
ABSTRACT: Cancer drugs and indications newly approved by the US Food and Drug Administration, May 2007 â February 2009
Bendamustine (Treanda): For the treatment of chronic lymphocytic leukemia. Approved March 2008; For the treatment of indolent B-cell non-Hodgkin lymphoma. Approved November 2008.
Bevacizumab (Avastin): For use in metastatic breast cancer in combination with paclitaxel chemotherapy. Accelerated approval for this indication granted February 2008.
Bortezomib (Velcade): For patients with previously untreated multiple myeloma. Approved for this indication June 2008.
Dalteparin (Fragmin): To reduce the recurrence of symptomatic venous thromboembolism (VTE) in patients with cancer. Approved May 2007.
Degarelix (Degarelix for injection); For the treatment of prostate cancer. Approved December 2008.
Denileukin Diftitox (Ontak): Treatment of CD25+ CTCL. Full approval. October 2008.
Dexrazoxane (Totect): Treatment of extravasation symptoms (pain, burning, swelling, and redness near infusion site) resulting from intravenous anthracycline chemotherapy. Approved September 2007.
Docetaxel (Taxotere): Induction treatment in combination with cisplatin and fluorouracil of locally advanced squamous cell carcinoma of the head and neck. Approved September 2007. Doxorubicin HCl liposome injection (Doxil): Treatment in combination with bortezomib of previously untreated multiple myeloma patients or those who have received at least one prior line of therapy. Approved May 2007. Fosaprepitant dimeglumine for injection (Emend): Intravenous therapy for the prevention of chemotherapy-induced nausea and vomiting. Injectable formulation approved January 2008. Granisetron (Sancuso): Treatment of chemotherapy-induced nausea and vomiting. Approved September 2008.
Human Papillomavirus (HPV) vaccine (Gardasil): For the prevention of vaginal and vulvar cancer caused by HPV types 16 and 18 in girls and women aged 9 to 26 years. Approved for this indication September 2008.
Ixabepilone (Ixempra): For the treatment of breast cancer. Approved
Nilotinib (Tasigna): For the treatment of chronic myelogenous leukemia. Approved October 2007.
Oxymorphone HCl (Opana): An opioid analgesic for the relief of moderate-to-severe pain in patients requiring continuous, around-the-clock, opioid treatment for an extended period of time. Three new dosage strengths, 7.5 mg, 15 mg, and 30 mg, approved March 2008. Pemetrexed (Alimta): Treatment of first-line non-small-cell lung cancer. Approved September 2008. Plerixa for injection (Mozobil): For the treatment of non-Hodgkin lymphoma and multiple myeloma. Approved December 2008. Romiplostim (Nplate): For patients with chronic immune thrombocytopenic purpura ( ITP) who do not respond sufficiently to current treatments. Approved August 2008. Raloxifene hydrochloride (Evista): For reducing the risk of invasive breast cancer in postmenopausal women with osteoporosis and in postmenopausal women at high risk for invasive breast cancer. Approved September 2007. Sorafenib (Nexavar): For the treatment of patients with unresectable hepatocellular carcinoma ( HCC). Approved for this indication November 2007. Temsirolimus (Torisel): Treatment of renal cell carcinoma. Approved May 2007. Topotecan (Hycamtin): For the treatment of small-cell lung cancer. Approved October 2007.