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FDA批准rucaparib用于BRCA阳性晚期卵巢癌治疗

FDA approves rucaparib for BRCA-positive advanced ovarian cancer

发布者:Frontline Medical News 发布时间:2017-1-4

FDA加速批准rucaparib用于治疗已接受2种或2种以上化疗药物治疗,且肿瘤携带生殖系或体细胞BRCA基因突变的晚期卵巢癌患者。FDA还批准了与rucaparib同时使用的FoundationFocus CDxBRCA伴随诊断试剂盒,用于检测肿瘤组织BRCA1和BRCA2基因突变。

The Food and Drug Administration has granted accelerated approval to rucaparib for the treatment of women with advanced ovarian cancer who have been treated with two or more chemotherapies and whose tumors have a germline or somatic BRCA gene mutation. The FDA also approved the FoundationFocus CDxBRCA companion diagnostic for use with rucaparib to detect BRCA1 and BRCA2 gene mutations in the tumor tissue.

FDA声明指出,rucaparib(Rubraca)属于多聚ADP核酸聚合酶(PARP)抑制剂,其获批是基于2项单臂临床试验结果汇总分析显示,客观应答率(ORR)为54%,中位应答持续时间为9.2个月。

Approval of rucaparib (Rubraca), a poly ADP-ribose polymerase (PARP) inhibitor, was based on an objective response rate (ORR) of 54%, and a median duration of response of 9.2 months, in a pooled analysis of two, single-arm clinical trials, the FDA said in a statement.

入组2项试验中的106例受试者皆为BRCA突变晚期卵巢癌患者,且已接受了2种或2种以上化疗方案治疗。他们口服600 mg rucaparib,每日2次。FoundationFocus CDxBRCA伴随诊断试剂确认 96%的受试者肿瘤组织存在BRCA基因突变。BRCA1与BRCA2基因突变携带者ORR相似。

All 106 patients in the two trials had BRCA-mutated advanced ovarian cancer and had been treated with two or more chemotherapy regimens. They received rucaparib 600 mg orally twice daily. BRCA gene mutations were confirmed in 96% of participants with available tumor tissue using the FoundationFocus CDxBRCA companion diagnostic. ORR was similar for patients with a BRCA1 gene mutation or BRCA2 gene mutation.

对服用rucaparib的377例患者进行安全性评价,最常见的不良反应包括恶心、疲乏、呕吐、贫血、腹痛、味觉障碍、便秘、食欲下降、腹泻、血小板减少以及呼吸困难。较不常见但具有严重风险的不良反应包括骨髓增生异常综合征(MDS)、急性髓性白血病(AML)和胎儿损害。

Safety was evaluated in 377 patients who received the drug and the most common adverse reactions were nausea, fatigue, vomiting, anemia, abdominal pain, dysgeusia, constipation, decreased appetite, diarrhea, thrombocytopenia, and dyspnea. Less common, but serious risks, include myelodysplastic syndrome (MDS), acute myeloid leukemia (AML), and fetal harm.

FDA在其网站上指出,应在服药前及服药后每个月对患者进行血液学毒性监测,一旦确认患者出现MDS/AML,应停止服药。

Patients should be monitored for hematologic toxicity at baseline and monthly thereafter, and use of rucaparib should be discontinued if MDS/AML is confirmed, the FDA said on its website.

Rucaparib由Clovis Oncology公司上市销售,FoundationFocus CDxBRCA伴随诊断试剂盒由Foundation Medicine公司上市销售。

Rucaparib is marketed by Clovis Oncology. The FoundationFocus CDxBRCA companion diagnostic is marketed by Foundation Medicine. 

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来源: Frontline Medical News

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