2018-11-29翻译《美国食品及药物管理局在经过快速审查后通

FDA approves two cancer treatments after expedited reviews

美国食品及药物管理局在经过快速审查后通过了两个癌症治疗的方法。

The US Food and Drug Administration approved two cancer treatments, Vitrakvi and Xospata, this week after expedited reviews.

本周经过快速审查后，美国食品及药物管理局通过了两个癌症治疗的方法，分别是Vitrakvi和Xospata。

Vitrakvi, approved Monday, is "a treatment for adult and pediatric patients whose cancers have a specific genetic feature (biomarker)."

周一通过的治疗法Vitrakvi，是一个用于治疗患有特定基因特征癌症的成人和小儿科患者的方法。

The FDA said in a statement that it is the second approved cancer treatment that is based on a tumor biomarker instead of the place in the body where the tumor originated.

食品及药物管理局在声明中说这是第二个基于肿瘤标志物的受通过的癌症治疗方法，不同于以往基于病灶的治疗方法（不同于以往基于身体肿瘤原始生长处的治疗方法）。

Vitrakvi will be used for the treatment of solid tumors that have an NTRK (neurotrophic receptor tyrosine kinase) gene fusion that do not have a known resistance mutation, that are not metastatic or where surgical removal is likely to lead to severe morbidity, and that have no alternative treatments or have progressed after treatments.

Vitrakvi是用于治疗有NTRK(神经营养受体酪氨酸激酶)基因融合的肿瘤，该肿瘤没有发生已知的耐药性突变，还没有转移，手术摘除时会导致危重症，并且没有其他的治疗方法或治疗后已经得到改善。

NTRK genes are rare but occur in many types of cancer, the FDA said, such as mammary analogue secretory carcinoma and infantile fibrosarcoma.

FDA说神经营养受体酪氨酸激酶基因很稀少但是会在很多类型的癌症中出现，例如乳腺类似分泌癌和婴儿型纤维肉瘤。

Xospata tablets, approved Wednesday, are for the "treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation," according to the FDA.

FDA资料显示，周三通过的Xospata，是治疗复发性癌症或伴有FLT3突变的难治性急性髓系白血病的成年病人。

Alongside the tablets, the agency also approved a diagnostic to detect the mutation.

除了该药之外，FDA还通过了一个可以甄别该突变的诊断方法。

"Approximately 25 to 30 percent of patients with AML have a mutation in the FLT3 gene. These mutations are associated with a particularly aggressive form of the disease and a higher risk of relapse," Dr. Richard Pazdur, director of the FDA's Oncology Center of Excellence, said in the statement.

FDA卓越中心主任理查德博士在声明中说：“大约25%~30%的带有难治性急性髓系白血病的病人在他的FLT3基因中有了突变。这些突变带有非常具有侵略性的疾病和很高的复发性。”

AML is a rapidly progressing cancer that affects the numbers of normal blood cells and calls for continuous transfusions, the FDA said.

FDA说：难治性急性髓系白血病是一种快速演变的癌症，它能影响很多正常的血细胞，需要持续输血。

Both treatments were granted Priority Review designation.

两种治疗方法都获得了优先审查资格。

Priority Review, established in 1992, means the FDA aims to review the drug or treatment within six months, opposed to 10 months for a standard review.

优先审查，与1992年创建，意思是FDA会在六个月内审查某种药或治疗方法，相对于普通药审查时间是10个月。

"A Priority Review designation will direct overall attention and resources to the evaluation of applications for drugs that, if approved, would be significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications," the FDA says.

Both treatments also received orphan drug designation, a status granted to drugs for rare diseases or conditions.

FDA说：优先审查资格将会引导大家的注意力和资源往该药的应用评估靠拢，如果该药获得通过，将会对该病的治疗，诊断的安全性和有效性产生重大的提升，或者相较于一般药的应用可以防止严重情况的发生。

两种治疗方法都获得了唯一指定用药的资格，这种资格是批准给治疗稀有疾病和病症的药物的。

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