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Endocyte's ovarian cancer decision illustrates FDA, EMA divide on PFS
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.
Johnson & Johnson's Doxil liposomal doxorubicin is the only drug approved to treat platinum-resistant ovarian cancer in the U.S. and the EU. FDA granted it accelerated approval in 2000 based on three open-label, single-arm Phase II trials in