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    FDA Grants Orphan Drug Designation to Merck and Pfizer

    Morag Mcgreevey
    Sep. 25, 2015 12:30PM PST
    Life Science Investing

    Merck (NYSE:MRK) and Pfizer (NYSE:PFE) have announced that their investigational cancer immunotherapy for the treatment of Merkel cell carcinoma has received orphan drug designation from the FDA.

    Merck (NYSE:MRK) and Pfizer (NYSE:PFE) have announced that their investigational cancer immunotherapy for the treatment of Merkel cell carcinoma has received orphan drug designation from the FDA.
    According to an article on Pharmaceutical Processing:
    Each year, there are approximately 1,500 new cases of MCC diagnosed in the U.S.
    Avelumab (also referred to as MSB0010718C) is an investigational fully human monoclonal IgG1 antibody against programmed death-ligand 1 (anti-PD-L1). Merck and Pfizer are currently conducting a Phase II study (JAVELIN Merkel 200) to assess the safety and efficacy of avelumab in patients with metastatic MCC who have progressed after at least one prior chemotherapy regimen.
    Click here to read the full article on Pharmaceutical Processing.

     

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