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2016年4月,FDA批出2个新分子实体药品(表1),为治疗白血病药物Venclexta(venetoclax)和治疗帕金森性精神病药物Nuplazid(匹莫范色林)。1 Venclexta(venetoclax)Venclexta获“突破性治疗药物”、“孤儿药”指定和“优先审评”地位,通过加速审批程序获得了批准,被批准单药治疗携带染色体17p缺失突变(del 17p)以及之前已接受至少一种疗法的慢性淋巴细胞白血病(chronic lymphocytic leukemia,CLL)患者,FDA批准的协同诊断Vysis CLL FISH探针药盒来确证17p缺失的检测结
In April 2016, the FDA awarded two new molecular entity drugs (Table 1) for the treatment of leukemia drug Venclexta (venetoclax) and the treatment of Parkinson’s psychotropic drug Nuplazid (pimozidelin). 1 Venclexta (venetoclax) Venclexta was awarded a “breakthrough therapeutic drug”, “orphan drug” designation and “priority review” status, was approved through an accelerated approval process and was approved for monotherapy to carry a chromosomal 17p deletion Mutations (del 17p), as well as patients with chronic lymphocytic leukemia (CLL) who have previously received at least one regimen, the FDA approved Vysis CLL FISH Probe Kit to validate the 17p deletion test