Volasertib (BI-6727)

Mechanism of action

Polo-like kinase 1 (PLK1) inhibitor

Preliminary data

Acute myeloid leukemia

1. Döhner H, Lübbert M, Fiedler W, Fouillard L, Haaland A, Brandwein JM, Lepretre S, Reman O, Turlure P, Ottmann OG, Müller-Tidow C, Krämer A, Raffoux E, Döhner K, Schlenk RF, Voss F, Taube T, Fritsch H, Maertens J. Randomized, phase 2 trial comparing low-dose cytarabine with or without volasertib in AML patients not suitable for intensive induction therapy. Blood. 2014 Aug 28;124(9):1426-33. Epub 2014 Jul 8. link to original article link to PMC article PubMed

History of changes in FDA indication

• 4/14/2014: Granted FDA orphan drug status for treatment of acute myeloid leukemia.