Sunesis Pharmaceuticals, Inc. SNSS today announced that the company has submitted a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) for Vosaroxin for the treatment of acute myeloid leukemia in patients aged 60 years and older. The application is subject to validation by the EMA, a process which typically takes one month, before the formal regulatory review of the application begins.
"Submission of an MAA for vosaroxin in relapsed refractory AML was our top priority in 2015. This milestone brings us closer to delivering a new option to a patient population which has seen little improvement in treatment standards in the last 40 years," said Daniel Swisher, Chief Executive Officer of Sunesis. "We believe the European market opportunity is significant, and look forward to providing updates on our progress with the application throughout 2016."
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