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12:00 AM
May 09, 2011
 |  BioCentury  |  Regulation

Looking for better conditions

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 a total of 145 refractory patients that showed response rates of 22.2%, 17.1% and 0%.

FDA's willingness to approve Doxil based on marginal efficacy demonstrates the unmet need, according to Ron Ellis, president and CEO of Endocyte. In this setting, "overall survival is less than a year, and progression-free survival is just a matter of weeks," he said.

According to Ellis, there are 10,000-12,000 cases of platinum-resistant ovarian cancer in the U.S. each year. About 80% of these women will have tumors that express folate receptors. These tumors are particularly aggressive.

This 80% is the segment Endocyte is targeting.

EC145 is a conjugate consisting of a vinca alkaloid microtubule destabilizer connected via linker...

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