Italfarmaco announces U.S. FDA grants Fast Track Designation to givinostat (Duvyzat) in treatment of polycythemia vera

Italfarmaco S.p.A. announced  that the FDA has granted Fast Track designation to givinostat for the treatment of patients with polycythemia vera (PV), a rare haematologic cancer, for which treatment options are limited. “The FDA decision to grant givinostat Fast Track designation underscores the urgent need for innovative treatments for PV and highlights the potential of givinostat to make a meaningful difference,” said Dr. Paolo Bettica, Chief Medical Officer at Italfarmaco Group. “We look forward to working closely with the FDA as we plan for completion of our Phase III clinical trial.” The Phase III trial (NCT06093672) is currently enrolling patients with clinical sites open in Europe, the UK, Israel, and North America, with more sites expected soon. Givinostat has previously  received orphan drug designation by the FDA and the EMA for PV.