新型抗癌药Rubraca(rucaparib Tablets)-获FDA授权加速批准为治疗晚期卵巢癌
美国FDA加速批准（accelerated approval）新药Rubraca（rucaparib）片剂、首个PARP抑制剂作为单一疗法用于治疗携带有害BRCA突变（生殖系和/或体细胞）的晚期卵巢癌，这些妇女患者已经接受过两种或更多种化疗治疗手段。
根据美国国家癌症研究所（the National Cancer Institute）估计，2016年度约有2.2多万名妇女被诊断为卵巢癌，1.4万病人会因此而死亡。其中，大约15％至20％的卵巢癌患者携带BRCA基因突变。BRCA基因主要参与修复损伤的DNA，通常以此机制来防止肿瘤进一步发展。然而，这些基因的突变也可直接导致包括卵巢癌在内的某些癌症。
新药Rubraca是一种靶向聚ADP-核糖聚合酶（PARP）的抑制剂，可阻断参与修复受损DNA的PARP酶活性。当PARP的功能得到抑制，那些同时具有受损BRCA基因的癌细胞DNA不太可能得到修复，于是可导致癌细胞死亡，并可能减缓或停止肿瘤生长。
FDA的药品评价和研究中心中血液学和肿瘤办公室主任和FDA的卓越肿瘤中心代理主任Richard Pazdur，M.D.说：“今天的批准是我们正在见到开发靶向在在患者的基因中特异性突变引起的药物治疗癌症另一个实例，” “有这些基因异常对她们卵巢癌曽试用至少两种化疗治疗妇女现有一个另外的治疗选择。”为与Rubraca使用FDA还批准FoundationFocus CDxBRCA 协同诊断，它是被监管局批准的第一个下-一代-基于测序(NGS)-协调诊断。加速批准程序，突破性治疗指定和优先审评状态。孤儿药物指定
批准日期：2016年12月19日；公司：Clovis Oncology，Inc.
Rubraca Tablets(Rucaparib(CO-338))
RUBRACA Rx
Generic Name and Formulations:
Rucaparib 200mg, 300mg; tabs.
Company:
Clovis Oncology

Select therapeutic use: Gynecologic cancers
Indications for RUBRACA:
Monotherapy in patients with deleterious BRCA-mutation (germline and/or somatic) associated advanced ovarian cancer who have been treated with ≥2 prior lines of chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic test.

Adult:
Swallow whole. 600mg twice daily until disease progression or unacceptable toxicity. Dose modifications or adjustments for adverse reactions: 1st reduction: 500mg twice daily; 2nd reduction: 400mg twice daily; 3rd reduction: 300mg twice daily.

Children:
Not established.

Warnings/Precautions:
Monitor CBC at baseline and monthly thereafter; do not start therapy until recovery from hematological toxicity due to previous chemotherapy (Grade ≤1). Discontinue if myelodysplastic syndrome/acute myeloid leukemia (MDS/AML) is confirmed. Embryo-fetal toxicity. Pregnancy; avoid. Females of reproductive potential must obtain pregnancy test prior to initiating therapy. Use effective contraception during therapy and for at least 6 months after last dose. Nursing mothers: not recommended (during and for 2 weeks after last dose).

Pharmacological Class:
Poly (ADP-ribose) polymerase (PARP) inhibitor.

Adverse Reactions:
Nausea, fatigue, asthenia, vomiting, anemia, abdominal pain, dysgeusia, constipation, decreased appetite, diarrhea, thrombocytopenia, dyspnea, lab abnormalities (increased: creatinine, ALT/AST, cholesterol; decreased: hemoglobin, lymphocytes, platelets, ANC).

Generic Availability:
NO

How Supplied:
Tabs—60
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a6d46c03-bb1d-417b-b8e5-3bffe352fe29

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产地国家: 美国
原产地英文商品名:
Rubraca 200mg/Tablets 60Tablets/bottle
原产地英文药品名:
Rucaparib
中文参考商品译名:
Rubraca 200毫克/片 60片/瓶
中文参考药品译名:
Rucaparib
生产厂家英文名:
Clovis Oncology，Inc.
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产地国家: 美国
原产地英文商品名:
Rubraca 300mg/Tablets 60Tablets/bottle
原产地英文药品名:
Rucaparib
中文参考商品译名:
Rubraca 300毫克/片 60片/瓶
中文参考药品译名:
Clovis Oncology，Inc.