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Delcath Systems, Inc. Message Board

  • bagholder1 bagholder1 Apr 30, 2013 9:38 AM Flag

    Its all there in the conclusion


    There is no standard of care and no approved therapy for patients with unresectable, hepatic
    metastases from ocular melanoma. Thus, there is an unmet medical need for these patients.
    Treatment of this patient population with melphalan/PHP has been demonstrated to alter the
    disease course, as evidenced by the consistent, statistically significant, and clinically meaningful
    benefits seen with melphalan/PHP treatment across the tumor-related efficacy endpoints in the
    pivotal Phase 3 study. The toxicities associated with melphalan/PHP treatment ***************need to be viewed within the context of the aggressive natural history of disease in these patients and the ability of
    melphalan/PHP treatment to alter the disease course***************. The REMS is designed to maintain a
    positive risk-benefit for melphalan/PHP treatment.

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