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.

意大利制药公司宣布，FDA已授予givinostat快速通道资格，用于治疗真性红细胞增多症（PV）患者，这是一种治疗选择有限的罕见血液癌症。

“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

“FDA授予givinostat快速通道资格的决定强调了对PV创新治疗的迫切需求，并突显了givinostat可能带来的重要影响，”表示

Dr.

博士

Paolo Bettica, Chief Medical Officer at Italfarmaco Group

意大利法玛科集团首席医疗官保罗·贝蒂卡

. “We look forward to working closely with the FDA as we plan for completion of our Phase III clinical trial.” The Phase III trial (

“我们期待在计划完成第三阶段临床试验时与FDA密切合作。” 第三阶段试验 (

NCT06093672

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.

）目前正在欧洲、英国、以色列和北美开放临床站点招募患者，预计很快将有更多站点开放。Givinostat此前已获得FDA和EMA对PV的孤儿药认定。

Condition:

条件：

Polycythemia Vera

真性红细胞增多症

Type:

类型：

drug

药物