What's New from the Office of Oncology Drug Products

What's New from the Office of Oncology Drug Products

http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm093885.htm

2010

FDA granted approval to rituximab (Rituxan, Genentech), in combination with fludarabine and cyclophosphamide (FC), for the treatment of previously untreated and previously treated patients with chronic lymphocytic leukemia (CLL). More Information1 (February 18, 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 Information2 (February 16, 2010)


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 Information3 (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 Information4 (October 26, 2009)

FDA granted approval to pazopanib tablets (VOTRIENTTM, GlaxoSmithKline) for the treatment of patients with advanced renal cell carcinoma. More Information5 (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 Information6 (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 7(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 Information8 (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 Information9 (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 Information10 (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 Information11 (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 Information12 (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 Information13 (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 Information14 (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 15(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 16(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 17(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 18(October 15)


FDA approves Alimta Injection for Treatment of Metastatic Non-Aquamous Non-Small Cell Lung Cancer (NSCLC).
More information19 (October 2)


FDA approves iobenguane I 123 injection for the detection of primary or metastatic pheochromocytoma or neuroblastoma.
More information20 (September 19)


FDA approves romiplostim (Nplate) for the treatment of thrombocytopenia. More information21 (August 22)


Velcade (bortezomib) is approved for initial treatment of Patients with Multiple Myeloma. More information22 (June 24)


FDA approves bendamustine hydochloride (Treanda) for the treatment of patients with chronic lymphocytic leukemia (CLL). More information23 (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 information24 (Feb. 22)
2007

FDA approves sorafenib (Nexavar) for the treatment of unresectable hepatocellular carcinoma. More information25 (Nov. 19)
FDA grants accelerated approval of a new dosing regimen of Dasatinib (Sprycel) More information26 (Nov. 8)
FDA approves safety-related product labeling changes for the erythropoiesis-stimulating agents Epogen, Procrit, and Aranesp. (Nov. 8) More information27
FDA grants accelerated approval to nilotinib (Tasigna) to treat leukemia. More information28 (Oct. 30)
FDA approves ixabepilone for injection (Ixempra) for two indications. More information29 (Oct. 16)

FDA expands labeling for cetuximab (marketed as Erbitux). More information30 (Oct. 2)


FDA approves new uses for docetaxel (Taxotere). More information31 (Sep. 28)


FDA approves new uses for raloxifene hydrochloride (Evista). More information32 (Sept. 13)


Dexrazoxane hydrochloride (Totect) was approved for the treatment of anthracycline extravasation. More information33 (Sept. 6)


Temsirolimus (Torisel) was approved for the treatment of advanced renal cell carcinoma. More information34 (May 30)


Doxorubicin HCl liposome injection (Doxil) was approved for use in combination with bortezomib in patients with multiple myeloma. More information35 (May 17)


A new indication for dalteparin sodium injection (Fragmin) was approved. More information36 (May 1)


Eculizumab injection (Soliris) was approved for the treatment of paroxysmal nocturnal hemoglobinuria. More information37 (March 16)


Lapatinib tablets (Tykerb) was approved for advanced metastatic breast cancer patients. More information38 (March 13)


FDA approved labeling changes for erythropoiesis-stimulating agents (ESAs) epoetin alfa (marketed as Procrit, Epogen), darbepoetin alfa (marketed as Aranesp) More information39 (March 9)


FDA was notified of the results from a multicenter, double-blind, randomized, placebo-controlled study of darbepoetin alfa (Aranesp) More information40 (Feb. 22)


FDA converted approval from accelerated to regular for sunitinib malate (Sutent) for the treatment of advanced renal cell carcinoma. More information41 (Feb. 2)

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