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Pre-approval

Long-term safety and efficacy of givinostat in polycythemia vera: 4-year mean follow up of three phase 1/2 studies and a compassionate use program
Authors:Alessandro Rambaldi, Alessandra Iurlo, Alessandro M. Vannucchi, Bruno Martino, Attilio Guarini, Marco Ruggeri, Nikolas von Bubnoff, Marianna De Muro, Mary Frances McMullin, Stefania Luciani, Vincenzo Martinelli, Axel Nogai, Vittorio Rosti, Alessandra Ricco, Paolo Bettica, Sara Manzoni and Silvia Di Tollo
Source:Blood Cancer J. 11, 53 (2021), doi.org/10.1038/s41408-021-00445-z
Givinostat: an emerging treatment for polycythemia vera
Authors:Helen T. Chifotides , Prithviraj Bose & Srdan Verstovsek
Source:Expert Opinion on Investigational Drugs, 29:6, 525-536, doi.org/10.1080/13543784.2020.1761323
Safety and efficacy of the maximum tolerated dose of givinostat in polycythemia vera: a two-part Phase Ib/II study
Authors:Alessandro Rambaldi, Alessandra Iurlo, Alessandro M. Vannucchi, Richard Noble, Nikolas von Bubnoff, Attilio Guarini, Bruno Martino, Antonio Pezzutto, Giuseppe Carli, Marianna De Muro, Stefania Luciani, Mary Frances McMullin, Nathalie Cambier, Jean-Pierre Marolleau, Ruben A. Mesa, Raoul Tibes, Alessandro Pancrazzi, Francesca Gesullo, Paolo Bettica, Sara Manzoni, Silvia Di Tollo
Source:Leukemia 34, 2234–2237 (2020), doi.org/10.1038/s41375-020-0735-y
Histological effects of givinostat in boys with Duchenne muscular dystrophy.
Authors:Bettica P, Petrini S, D'Oria V, D'Amico A, Catteruccia M, Pane M, Sivo S, Magri F, Brajkovic S, Messina S, Vita GL, Gatti B, Moggio M, Puri PL, Rocchetti M, De Nicolao G, Vita G, Comi GP, Bertini E, Mercuri E.
Source:Neuromuscul Disord. 2016 Oct;26(10):643-649. doi: 10.1016/j.nmd.2016.07.002. Epub 2016 Jul 11. PubMed PMID: 27566866.
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.