FDA Grants Volasertib Breakthrough Therapy Designation in AML


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Boehringer Ingelheim Pharmaceuticals, Inc, has announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to volasertib, an investigational inhibitor of polo-like kinase (Plk), which being evaluated for the treatment of patients aged 65 or older with previously untreated acute myeloid leukemia who are ineligible for intensive remission induction therapy.

Volasertib is designed to inhibit the activity of Plk1, an enzyme in the Plk family that regulates mitosis.  This inhibition is intended to result in prolonged cell cycle arrest, ultimately leading to cell death.

“This FDA Breakthrough Therapy designation provides Boehringer Ingelheim the opportunity to engage in an ongoing dialogue with the FDA  to help expedite the development of volasertib as a potential treatment option for these patients with [acute myeloid leukemia],” said Sabine Luik, MD, Senior Vice President, Medicine & Regulatory Affairs, Boehringer Ingelheim Pharmaceuticals, Inc.

Clinical Trials

Results from a phase II study in newly diagnosed patients with acute myeloid leukemia considered ineligible for intensive remission induction therapy demonstrated higher rates of objective response and an improvement in event-free survival in patients receiving volasertib in combination with low-dose cytarabine compared to patients receiving low-dose cytarabine alone. The results were presented at the 54th American Society of Hematology Annual Meeting in December 2012.

These results led to the initiation in January 2013 of a phase III trial, POLO-AML-2, to assess the efficacy and safety of volasertib in combination with low-dose cytarabine, compared to placebo in combination with low-dose cytarabine, in patients aged 65 or older with previously untreated acute myeloid leukemia who are ineligible for intensive remission induction therapy. The trial is currently enrolling eligible patients. ■



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