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Volasertib Receives FDA ‘Breakthrough Therapy’ Designation for Treatment of Leukemia
The FDA has granted a Breakthrough Therapy designation to volasertib, an investigational inhibitor of polo-like kinase (Plk), which is being evaluated for the treatment of patients aged 65 years or older with previously untreated acute myeloid leukemia (AML) who are ineligible for intensive remission-induction therapy.
Results from a phase II study in newly diagnosed patients with AML considered to be 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 (LDAC) compared with patients receiving LDAC alone. The results were presented at the 54th American Society of Hematology (ASH) annual meeting in December 2012.
These results led to the initiation in January 2013 of a phase III trial, POLO-AML-2. This study is designed to assess the efficacy and safety of volasertib in combination with LDAC, compared with placebo in combination with LDAC, in patients aged 65 years or older with previously untreated AML who are ineligible for intensive remission-induction therapy. The trial is currently enrolling eligible patients.
Volasertib is designed to inhibit the activity of Plk1, an enzyme in the Plk family that regulates cell mitosis. This inhibition is intended to result in prolonged cell-cycle arrest, ultimately leading to apoptosis.
Source: Boehringer Ingelheim; September 17, 2013.