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Pre-approval

Givinostat for the treatment of polycythemia vera.
Authors:Pieri L, Guglielmelli P, Finazzi G, Vannucchi AM.
Source:Expert Opinion on Orphan Drugs (2014) 2(8): 841-850. doi: 10.1517/21678707.2014.934223.
A phase II study of Givinostat in combination with hydroxycarbamide in patients with polycythaemia vera unresponsive to hydroxycarbamide monotherapy.
Authors:Finazzi G, Vannucchi AM, Martinelli V, Ruggeri M, Nobile F, Specchia G, Pogliani EM, Olimpieri OM, Fioritoni G, Musolino C, Cilloni D, Sivera P, Barosi G, Finazzi MC, Di Tollo S, Demuth T, Barbui T, Rambaldi A.
Source:Br J Haematol. 2013 Jun;161(5):688-94. doi: 10.1111/bjh.12332. Epub 2013 Apr 10.
Safety and efficacy of an oral histone deacetylase inhibitor in systemic-onset juvenile idiopathic arthritis.
Authors:Vojinovic J, Damjanov N, D'Urzo C, Furlan A, Susic G, Pasic S, Iagaru N, Stefan M, Dinarello CA.
Source:Arthritis Rheum. 2011 May;63(5):1452-8. doi: 10.1002/art.30238.
Pharmacokinetics, safety and inducible cytokine responses during a phase 1 trial of the oral histone deacetylase inhibitor ITF2357 (givinostat).
Authors:Furlan A, Monzani V, Reznikov LL, Leoni F, Fossati G, Modena D, Mascagni P, Dinarello CA.
Source:Mol Med. 2011 May-Jun;17(5-6):353-62. doi: 10.2119/molmed.2011.00020. Epub 2011 Feb 22.
A pilot study of the Histone-Deacetylase inhibitor Givinostat in patients with JAK2V617F positive chronic myeloproliferative neoplasms.
Authors:Rambaldi A, Dellacasa CM, Finazzi G, Carobbio A, Ferrari ML, Guglielmelli P, Gattoni E, Salmoiraghi S, Finazzi MC, Di Tollo S, D'Urzo C, Vannucchi AM, Barosi G, Barbui T.
Source:Br J Haematol. 2010 Aug;150(4):446-55. doi: 10.1111/j.1365-2141.2010.08266.x. Epub 2010 Jun 15.
A phase II multiple dose clinical trial of histone deacetylase inhibitor ITF2357 in patients with relapsed or progressive multiple myeloma.
Authors:Galli M, Salmoiraghi S, Golay J, Gozzini A, Crippa C, Pescosta N, Rambaldi A.
Source:Ann Hematol. 2010 Feb;89(2):185-90. doi: 10.1007/s00277-009-0793-8. Epub 2009 Jul 25.