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FDA accepts Bristol-Myers' application for expanded use of Yervoy

  • The FDA accepts for review Bristol-Myers Squibb's (BMY +1.6%) supplemental Biologics License Application (sBLA) seeking approval for the use of Yervoy (ipilimumab) as adjuvant treatment for patients with stage 3 melanoma who are at high risk of recurrence following complete surgical resection. The PDUFA date is October 28.
  • Patients in this category ave a poor prognosis. Once the cancer returns, the survival rates are only 11 - 20%.
  • Yervoy is currently cleared for the treatment of adults with metastatic or unresectable melanoma.
  • Ipilimumab is a human monoclonal antibody that blocks the cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4), a protein receptor that downregulates the immune system.

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