Difference between revisions of "Volasertib (BI-6727)"
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=Preliminary data= | =Preliminary data= | ||
==[[Acute myeloid leukemia]]== | ==[[Acute myeloid leukemia]]== | ||
| − | # 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 Jul 8. | + | # 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. [http://bloodjournal.hematologylibrary.org/content/early/2014/07/07/blood-2014-03-560557.long link to original article] [http://www.ncbi.nlm.nih.gov/pubmed/25006120 PubMed] |
=History of changes in FDA indication= | =History of changes in FDA indication= | ||
Revision as of 04:21, 21 November 2014
Mechanism of action
Polo-like kinase 1 (PLK1) inhibitor
Preliminary data
Acute myeloid leukemia
- 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 PubMed
History of changes in FDA indication
- 4/14/2014: Granted FDA orphan drug status for treatment of acute myeloid leukemia.