Will Weak Standard Of Care Lower Approval Bar For PegIntron For Melanoma?
Executive Summary
FDA may be more likely to approve Schering-Plough's PegIntron for melanoma based on a modest improvement in relapse-free survival, without an effect on overall survival, with support from its Oncologic Drugs Advisory Committee that the survival advantage for the standard of care - Schering's own Intron A - is questionable