Boehringer Ingelheim announced that the FDA has granted Breakthrough Therapy designation to volasertib for the treatment of patients ≥65 years old with previously untreated acute myeloid leukemia (AML), ineligible for intensive remission induction therapy. Volasertib is an investigational inhibitor of polo-like kinase (Plk), designed to inhibit the activity of Plk1, an enzyme in the Plk family that regulates cell division resulting in prolonged cell cycle arrest, ultimately leading to cell death.
Results from a Phase 2 study in newly diagnosed patients with AML 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 (LDAC) compared to patients receiving LDAC alone.
These results led to the initiation of a Phase 3 trial, POLO-AML-2 in January 2013. This trial is designed to assess the efficacy and safety of volasertib in combination with LDAC, compared to placebo in combination with LDAC, in patients ≥65 years old with previously untreated AML, ineligible for intensive remission induction therapy. The trial is currently enrolling eligible patients.
For more information call (800) 542-6257 or visit Boehringer-Ingelheim.com
This article originally appeared on MPR