Bendamustine hydrochloride (Treanda): For the treatment of patients with indolent B-cell non-Hodgkin lymphoma (NHL). Approved October 2008.

Bevacizumab (Avastin): In combination with interferon alfa (Intron A) as a single agent for patients with glioblastoma, with progressive disease following prior therapy. Approved May 2009; for the treatment of patients with metastatic renal cell carcinoma. Approved August 2009.

Cetuximab (Erbitux): KRAS mutations changes were made to the product label. Full prescribing information for cetuximab, including clinical trial information, safety, dosing, drug-drug interaction, contraindications is available at http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125084s168lbl.pdf

Degarelix for injection (Firmagon): For the treatment of patients with advanced prostate cancer. Approved December 2008.

Denileukin diftitox (Ontak): For intravenous use for the treatment of persistent or recurrent CD-25 positive cutaneous T-cell lymphoma. Approval October 2008.

Eltrombopag (Promacta): For the treatment of thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenic purpura. Approved November 2008.

Everolimus tablets (Affinitor): For treatment of patients with advanced renal cell carcinoma after failure of treatment with sunitinib (Sutent) or sorafenib (Nexavar). Approved March 2009.

Ferumoxytol (Feraheme Injection): For the treatment of iron deficiency anemia in adult patients with chronic kidney disease. Approved June 2009.

HPV Vaccine (Cervarix): To prevent cervical cancer and precancerous lesions caused by HPV types 16 and 18. Indicated for use in girls and women ages 10 to 25 years. Approved October 2009.

Imatinib mesylate (Gleevec): For the adjuvant treatment of adult patients following complete gross resection of Kit (CD117) positive gastrointestinal stromal tumor (GIST). Approved December 2008.

Iobenguane I 123 injection (AdreView): For the detection of primary or metastatic pheochromocytoma or neuroblastoma. Approved September 2008.

Ofatumumab (Arzerra): For treatment of chronic lymphocytic leukemia in patients whose cancer is no longer controlled by other drugs. Approved October 2009.

Panitumumab (Vectibix): KRAS mutations changes were made to the product label. Full prescribing information for panitumumab, including clinical trial information, safety, dosing, drug-drug interaction, contraindications is available at http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125147s080lbl.pdf

Pazopanib (Votrient): For treatment of advanced renal cell carcinoma. Approved October 2009.

Pemetrexed (Alimta): For treatment of metastatic non-squamous non-small cell lung cancer (NSCLC). Approved October 2008; for maintenance treatment of locally advanced or metastatic nonsquamous non-small cell lung cancer patients with no disease progression after four cycles of platinum-based first-line chemotherapy. Approved July 2009.

Plerixafor (Mozobil): For use in combination with granulocyte-colony stimulating factor (G-CSF) to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with non-Hodgkin lymphoma (NHL) and multiple myeloma (MM). Approved December 2008.

Pralatrexate injection (Folotyn): For the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). Approved September 2009.

Romidepsin (Istodax): For the treatment of patients with previously treated cutaneous T-cell lymphoma (CTCL). Approved November 2009.

For additional information and an up-to-date listing of newly approved oncology drugs, see FDA’s “What’s New From the Office of Oncology Drug Products” at http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm093885.htm.