What's New from the Office of Oncology Drug Products

What's New from the Office of Oncology Drug Products
2009

.FDA granted approval to romidepsin for injection (ISTODAX, Gloucester Pharmaceuticals Inc.) for the treatment of cutaneous T-cell lymphoma (CTCL) in patients who have received at least one prior systemic therapy. More Information (November 6, 2009)
..FDA granted accelerated approval to ofatumumab (Arzerra, GlaxoSmithKline) for the treatment of patients with chronic lymphocytic leukemia (CLL) refractory to fludarabine and alemtuzumab. More Information (October 26, 2009)
...FDA granted approval to pazopanib tablets (VOTRIENTTM, GlaxoSmithKline) for the treatment of patients with advanced renal cell carcinoma. More Information (October 19, 2009)
....FDA granted accelerated approval to pralatrexate injection (FOLOTYN, Allos Therapeutics, Inc.) for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). More Information (September 24, 2009)
.....FDA granted approval for the use of bevacizumab (Avastin, Genentech, Inc.) in combination with interferon alfa for the treatment of patients with metastatic renal cell carcinoma. More Information (July 31, 2009)
......FDA implemented Class Labeling Changes to anti-EGFR monoclonal antibodies, cetuximab (Erbitux) and panitumumab (Vectibix): KRAS Mutations changes were made to the product labels of cetuximab (Erbitux ImClone Systems, Branchburg, NJ) and panitumumab (Vectibix Amgen, Thousand Oaks, CA). More Information (July 17, 2009)
.......FDA approved pemetrexed (Alimta) 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. More Information (July 2, 2009)
........FDA approves ferumoxytol (Feraheme Injection, AMAG Pharmaceuticals, Inc.) for the treatment of iron deficiency anemia in adult patients with chronic kidney disease (CKD). Ferumoxytol is an iron-containing product for intravenous (IV) administration. More Information (June 30, 2009)
.........FDA granted accelerated approval to bevacizumab injection (Avastin, Genentech, Inc.) as a single agent for patients with glioblastoma, with progressive disease following prior therapy. More Information (May 5, 2009)
..........FDA approves everolimus tablets (AFINITOR, Novartis) for treatment of patients with advanced renal cell carcinoma after failure of treatment with sunitinib or sorafenib More Information (March 31, 2009)

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What's New from the Office of Oncology Drug Products