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Endocyte's ovarian cancer decision illustrates FDA, EMA divide on PFS
May 9, 2011 7:00 AM UTC
Endocyte Inc.'s plans for EC145 in ovarian cancer illustrate the divide between FDA and EMA on early approval of drugs based on progression-free survival. The company plans to seek conditional approval in the EU based on PFS data from a Phase II trial, after concluding accelerated approval from FDA would be unlikely based on the agency's recently strengthened guidelines.
As a result, U.S. approval in relapsed ovarian cancer patients could be at least three or four years away...