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Sunesis withdraws leukemia drug marketing application in Europe

Published 02 May 2017

Sunesis Pharmaceuticals said it will withdraw its European Marketing Authorization Application (MAA) for vosaroxin as a therapy for acute myeloid leukemia (AML) both in relapsed and refractory forms in patients aged 60 years and older.

The decision follows recent interactions with the European Medicine Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP), during which the Company learned that the committee was likely to formally adopt a negative opinion in its evaluation of the application.

Daniel Swisher, President and Chief Executive Officer of Sunesis said: “We are disappointed to not achieve approval for vosaroxin’s MAA given its reported efficacy in a patient population with such poor outcomes.  Although we did not receive a definitive CHMP opinion, we believed that a positive opinion was unlikely.

“Following our appearances before the committee’s Scientific Advisory Group Oncology and CHMP, we carefully considered feedback from our rapporteurs and input from retained regulatory experts to make our decision to notify EMA to withdraw vosaroxin’s MAA as our assessment concluded it was unlikely we could achieve a majority vote of CHMP members at this time or upon an immediate re-examination for our proposed indication based on VALOR data from a sub-group of a single pivotal trial that had missed reaching full statistical significance in its primary analysis.”

Swisher added: “In light of this, we are significantly reducing our investment in the AML program and shifting an increasing portion of resources to our kinase inhibitor pipeline, including lead asset SNS-062, our non-covalent reversible BTK-inhibitor, which will begin dosing this quarter in a Phase 1b/2 trial in cancer patients with B-cell malignancies.

“We expect to continue to advance the development of vosaroxin through a modest investment in investigator-sponsored group trials, and will carefully assess business development alternatives to support the conduct of another pivotal trial to achieve future regulatory approval of vosaroxin. We expect that our current cash resources are sufficient to fund the company beyond Q1 2018.”

Source: Company Press Release