Italfarmaco announces US FDA grants fast track designation to givinostat in treatment of polycythemia vera

Italfarmaco

6 May 2025 - Italfarmaco announced today that the US FDA has granted fast track designation to givinostat for the treatment of patients with polycythemia vera, a rare haematologic cancer, for which treatment options are limited.

The Phase 3 trial is currently enrolling patients with clinical sites open in Europe, the UK, Israel, and North America, with more sites expected soon.

Read Italfarmaco press release

Michael Wonder

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Michael Wonder

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Medicine , US , Fast track