What's New from the Office of Oncology Drug Products

What's New from the Office of Oncology Drug Products


2010
FDA approved a risk evaluation and mitigation strategy (REMS) to ensure the safe use of Erythropoiesis-Stimulating Agents (ESAs). The medications included in the program are marketed by Amgen under the names Aranesp (darbepoetin alfa) and Epogen (epoetin alfa) and by Centocor Ortho Biotech Products under the name Procrit (epoetin alfa). FDA required Amgen, the manufacturer of these products, to develop the REMS based on studies demonstrating that use of ESAs can increase the risk of tumor growth and shorten survival in patients with cancer. More Information (February 16, 2010)
http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm200847.htm

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)

2008
FDA approved degarelix for injection (Ferring Pharmaceuticals Inc., Parsippany, NJ), a new gonadotropin releasing hormone (GnRH) receptor antagonist, for the treatment of patients with advanced prostate cancer. More Information (December 24, 2008)

FDA approved imatinib mesylate tablets for oral use (Gleevec, Novartis Pharmaceuticals) for the adjuvant treatment of adult patients following complete gross resection of Kit (CD117) positive Gastrointestinal Stromal Tumor (GIST). More Information (December 19, 2008)

FDA approved plerixafor, solution for subcutaneous injection, (Mozobil, Genzyme Corp.) 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’s lymphoma (NHL) and multiple myeloma (MM). More Information (December 15, 2008)

FDA granted accelerated approval for eltrombopag tablets (Promacta, GlaxoSmithKline Inc.) for the treatment of thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenic purpura (ITP) More Information (November 20)

FDA approved bendamustine hydrochloride (TREANDA, Cephalon, Inc.), for the treatment of patients with indolent B-cell non-Hodgkin’s lymphoma (NHL) More Information (October 31)

FDA converted the approval of Denileukin diftitox (Ontak, Eisai Medical Research) solution for intravenous use for the treatment of persistent or recurrent CD-25 positive cutaneous T-cell lymphoma. More information (October 15)

FDA approves Alimta Injection for Treatment of Metastatic Non-Aquamous Non-Small Cell Lung Cancer (NSCLC).
More information (October 2)

FDA approves iobenguane I 123 injection for the detection of primary or metastatic pheochromocytoma or neuroblastoma.
More information (September 19)

FDA approves romiplostim (Nplate) for the treatment of thrombocytopenia. More information (August 22)

Velcade (bortezomib) is approved for initial treatment of Patients with Multiple Myeloma. More information (June 24)

FDA approves bendamustine hydochloride (Treanda) for the treatment of patients with chronic lymphocytic leukemia (CLL). More information (March 20)

Bevacizumab (Avastin) was granted accelerated approval for use in combination with paclitaxel for the treatment of patients who have not received chemotherapy for metastatic HER2 negative breast cancer. More information (Feb. 22)
2007
FDA approves sorafenib (Nexavar) for the treatment of unresectable hepatocellular carcinoma. More information (Nov. 19)
FDA grants accelerated approval of a new dosing regimen of Dasatinib (Sprycel) More information (Nov. 8)
FDA approves safety-related product labeling changes for the erythropoiesis-stimulating agents Epogen, Procrit, and Aranesp. (Nov. 8) More information
FDA grants accelerated approval to nilotinib (Tasigna) to treat leukemia. More information (Oct. 30)
FDA approves ixabepilone for injection (Ixempra) for two indications. More information (Oct. 16)
FDA expands labeling for cetuximab (marketed as Erbitux). More information (Oct. 2)

FDA approves new uses for docetaxel (Taxotere). More information (Sep. 28)

FDA approves new uses for raloxifene hydrochloride (Evista). More information (Sept. 13)

Dexrazoxane hydrochloride (Totect) was approved for the treatment of anthracycline extravasation. More information (Sept. 6)

Temsirolimus (Torisel) was approved for the treatment of advanced renal cell carcinoma. More information (May 30)

Doxorubicin HCl liposome injection (Doxil) was approved for use in combination with bortezomib in patients with multiple myeloma. More information (May 17)

A new indication for dalteparin sodium injection (Fragmin) was approved. More information (May 1)

Eculizumab injection (Soliris) was approved for the treatment of paroxysmal nocturnal hemoglobinuria. More information (March 16)

Lapatinib tablets (Tykerb) was approved for advanced metastatic breast cancer patients. More information (March 13)

FDA approved labeling changes for erythropoiesis-stimulating agents (ESAs) epoetin alfa (marketed as Procrit, Epogen), darbepoetin alfa (marketed as Aranesp) More information (March 9)

FDA was notified of the results from a multicenter, double-blind, randomized, placebo-controlled study of darbepoetin alfa (Aranesp) More information (Feb. 22)

FDA converted approval from accelerated to regular for sunitinib malate (Sutent) for the treatment of advanced renal cell carcinoma. More information (Feb. 2)
Previous News Items
http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm093885.htm