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Hematology/Oncology (cancer) Approvals & Safety Notifications: Previous News Items

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)

2006

  • On December 8, FDA granted approval to bortezomib (Velcade), a proteasome inhibitor, for the treatment of patients with mantle cell lymphoma who have received at least one prior therapy. More information  
  • On November 16, FDA approved the expanded use of trastuzumab (Herceptin) for early stage breast cancer after primary therapy. More information 
  • On October 19, FDA approved imatinib mesylate (Gleevec) as a single agent for the treatment of multiple indications. More information 
  • On October 17, FDA approved docetaxel (Taxotere) for use in combination with cisplatin and fluorouracil for the induction treatment of patients with inoperable, locally advanced squamous cell carcinoma of the head and neck. More information 
  • On October 11, FDA approved bevacizumab (Avastin) as a first-line treatment of patients with locally advanced, metastatic or recurrent non-small cell lung cancer in combination with platinum-based chemotherapy. More information 
  • On October 6, FDA granted approval to vorinostat (Zolinza), a histone deacetylase inhibitor, for the treatment of cutaneous manifestations of cutaneous T-cell lymphoma (CTCL) in patients with progressive, persistent, or recurrent disease on or following two systemic therapies. More information  
  • On September 29, FDA approved two rituximab (Rituxan) supplemental applications for the first-line treatment of patients with low grade or follicular, CD20-positive B-cell non-Hodgkin’s lymphoma. More information
  • On September 27, FDA approved imatinib mesylate (Gleevec) as a single agent for the treatment of pediatric patients with newly diagnosed Philadelphia chromosome positive chronic myelogenous leukemia (Ph+ CML). More information  
  • On September 27, FDA approved panitumumab (vectibix) to treat metastatic colorectal carcinoma. More Information. More information 
  • On September 21, FDA approved changed in the Avastin package insert regarding warning and dose and administration for Reversible Posterior Leukoencephalopathy Syndrome. Nasal septum perforation was also added as a serious adverse event. More information 
  • On September 13, FDA approved changes to the product labeling for oprelvekin (Neumega) to include new warnings on ophthalmologic and ventricular arrhythmias adverse events. More information
  • On July 24, FDA approved pegaspargase (Oncaspar, Enzon Pharmaceuticals, Inc) for the first-line treatment of patients with acute lymphoblastic leukemia. More information 
  • On July 14, FDA approved gemcitabine (Gemzar) in combination with carboplatin for the treatment of patients with advanced ovarian cancer that has relapsed at least 6 months after completion of platinum based therapy. More information 
  • On June 29, FDA approved lenalidomide oral capsules (Revlimid), Celgene Corporation) for use in combination with dexamethasone in patients with multiple myeloma who have received one prior therapy. More information 
  • On June 28, FDA approved dasatinib (Sprycel) for use in the treatment of adults  with chronic phase, accelerated phase, or myeloid or lymphoid blast phase chronic myeloid leukemia. More information 
  • On June 20, FDA approved the labeling extension for bevacizumab (Avastin) for second-line treatment of metastatic carcinoma of the colon or rectum. More information 
  • On June 14, FDA approved topotecan hydrochloride (Hycamtin) in combination with cisplatin for the treatment of Stage IVB recurrent or persistent carcinoma of the cervix. More information 
  • Dr. Robert Justice Selected as the Director of the Division of Drug Oncology Products. More Information 
  • On June 8, FDA licensed Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (Gardasil) for the prevention of cervical cancer and other diseases in females caused by Human Papillomavirus. More information
  • On May 26, FDA granted accelerated approval for thalidomide (Thalomid) in combination with dexamethasone for the treatment of newly diagnosed multiple myeloma (MM) patients. More Information 
  • On May 2, FDA approved decitabine for injection (Dacogen) for the treatment of patients with myelodysplastic syndromes (MDS). More Information 
  • On March 3, the Division of Biologic Oncology Products in FDA's Office of Oncology Drug Products (OODP) approved changes to the product labeling for denileukin diftitox (Ontak) to include a new warning on ophthalmologic adverse events. More information 
  • On March 1, FDA granted approval to cetuximab (Erbitux) for use in combination with radiation therapy (RT) for the treatment of locally or regionally advanced squamous cell carcinoma of the head and neck (SCCHN) or as a single agent for the treatment of patients with recurrent or metastatic SCCHN for whom prior platinum-based therapy has failed. More information 
  • On February 10, FDA granted approval to rituximab (Rituxan) for use in the first‑line treatment of patients with diffuse large B-cell, CD20‑positive, non-Hodgkin's lymphoma in combination with CHOP or other anthracycline‑based chemotherapy regimens. More information