PharmaNews.EU reported yesterday (with a H/T to my erstwhile anonymous commenter(s)!) that Cylatron, or Peginterferon Alpha-2b, is no longer on the list to be approved (for Stage III melanoma) by EU regulatory authorities, due to a determination by Schering-Plough itself that the risk-benefit ratio isn't sufficient, given the study data:
. . . .At the time of the withdrawal, it was under review by the Agency’s Committee for Medicinal Products for Human Use (CHMP). In its official letter, the company stated that the withdrawal of the application was based on the CHMP's view that the data provided were not sufficient to allow the Committee to conclude on a positive benefit-risk balance for Cylatron at that time. . . .
What does this mean for its prospects in the US? [