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  • 18 Aug 2017 3:43 PM | Lori Aubrey (Administrator)

    Reagan-Udall Foundation for the FDA Launches Expanded Access Navigator Website

    The nonprofit Reagan-Udall Foundation for the Food and Drug Administration has released a new, online resource called the Expanded Access Navigator. The website, which focuses on oncology with plans to expand to other disease areas, features the first pharmaceutical company directory of expanded access policies and criteria, as well as educational resources, guides and downloadable forms. ASCO was one of several organizations to help develop the Navigator.

    The Navigator guides patients and physicians through the complicated process often called compassionate use, beginning with assessing whether all approved therapeutic options for patients with serious or life-threatening conditions are exhausted. If no clinical trials or expanded access programs are available or accessible, the Navigator acts as a clearinghouse for the single-patient expanded access policies of dozens of leading biopharmaceutical companies.

    ASCO, the American Cancer Society, the Biotechnology Industry Association, FDA, Foundation Medicine, PhRMA and Susan G. Komen helped develop the Navigator along with the support of Bristol-Meyers Squibb, Genentech, Janssen, Lilly, Merck and Pfizer
  • 01 Aug 2017 4:35 PM | Lori Aubrey (Administrator)

    FDA grants nivolumab accelerated approval for MSI-H or dMMR colorectal cancer

    FDA Approvals

  • 12 May 2017 8:47 AM | Lori Aubrey (Administrator)

    New FDA approval for pembrolizumab

    FDA Approvals

  • 09 May 2017 12:41 PM | Lori Aubrey (Administrator)
    • avelumab
    • brigatinib
  • 15 Mar 2017 1:47 PM | Lori Aubrey (Administrator)
  • 14 Mar 2017 8:33 AM | Lori Aubrey (Administrator)

    FDA Approvals - FDA approves ribociclib

  • 23 Feb 2017 10:26 AM | Lori Aubrey (Administrator)
  • 03 Feb 2017 6:32 PM | Lori Aubrey (Administrator)

    FDA granted accelerated approval to nivolumab (OPDIVO, Bristol-Myers Squibb Company) for treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with a platinum-containing chemotherapy.   February 2, 2017. More Information: http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm539646.htm

     


Northern New England Clinical Oncology Society
P.O. Box 643
Sandown, NH 03873-0643
Telephone (603) 887-1948
info@nnecos.org

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