• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

About FDA

  • Print
  • Share
  • E-mail

What's New (Hematology/Oncology (Cancer) Approvals & Safety Notifications) Past years

For current updates, please see Hematology/Oncology (Cancer) Approvals & Safety Notifications

 

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