2015年4月29日，CYRAMZA在美国FDA获批，与FOLFIRI方案联合用于转移性结直肠癌的二线治疗。这是FDA对于CYRAMZA的第四项批准。目前，Cyramza（ramucirumab注射液10mg/mL溶液）还可联合FOLFIRI（伊立替康、叶酸和5-氟尿嘧啶）化疗用于贝伐单抗、奥沙利铂和氟嘧啶治疗期间或治疗后出现疾病进展的转移性结直肠癌（mCRC）患者。
礼来制药高级副总裁、抗肿瘤事业部总裁Sue Mahony博士表示：“在一年内，CYRAMZA已获得FDA第四项批准，现已获准用于世界上最常见且最致命的晚期或转移性的三种癌症治疗（即胃癌、非小细胞型肺癌和结直肠癌）。这种进展鼓舞着我们，支持我们继续进行CYRAMZA研发计划。今天的这一里程碑再次印证了礼来对胃肠癌患者所做出的承诺。”
Mahony博士补充道：“同时，我们很高兴就这些申报与FDA开展富有成效的合作审查。”虽然接受的是标准审查，CYRAMZA这项针对mCRC的申请在提交给FDA大约9周后获得了审核批准。CYRAMZA的所有三项补充性申请都在提交后6个月内获得FDA批准。
此次获批是基于称为“RAISE”的III期试验，该试验比较了CYRAMZA 联合FOLFIRI与安慰剂联合FOLFIRI用于既往贝伐单抗、奥沙利铂和氟嘧啶治疗期间或治疗后出现疾病进展的mCRC患者。该试验的疗效终点包括主要有效性结果评估，即总生存期（OS），以及支持性有效性结果评估，即无疾病进展生存期（PFS）。
CYRAMZA的产品标签包含下列黑框警示：出血，包括可能导致严重的、甚至危及生命的出血事件；胃肠道（GI）穿孔，一种可能导致死亡的事件以及伤口愈合受损。如果患者出现严重出血或GI穿孔，就应当永久性地停止使用CYRAMZA。CYRAMZA应在手术前暂停，如果患者出现伤口愈合并发症，就应终止用药。
请见处方资料。
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use CYRAMZA safely and effectively. See full prescribing information for CYRAMZA.
CYRAMZA (ramucirumab) injection, for intravenous use
Initial U.S. Approval: 2014
WARNING: HEMORRHAGE, GASTROINTESTINAL PERFORATION, AND IMPAIRED WOUND HEALING See full prescribing information for complete boxed warning.
Hemorrhage: CYRAMZA increased the risk of hemorrhage, and gastrointestinal hemorrhage, including severe and sometimes fatal hemorrhagic events. Permanently discontinue CYRAMZA in patients who experience severe bleeding. (2.3, 5.1)
Gastrointestinal Perforation: Permanently discontinue CYRAMZA in patients who experience a gastrointestinal perforation. (2.3, 5.5)
Impaired Wound Healing: Withhold CYRAMZA prior to surgery and discontinue CYRAMZA if a patient develops wound healing complications (2.3, 5.6)
RECENT MAJOR CHANGES
INDICATIONS AND USAGE
CYRAMZA® is a human vascular endothelial growth factor receptor 2 antagonist indicated
as a single agent or in combination with paclitaxel, for treatment of advanced gastric or gastro-esophageal junction adenocarcinoma, with disease progression on or after prior fluoropyrimidine- or platinum-containing chemotherapy. (1.1)
in combination with docetaxel, for treatment of metastatic non-small cell lung cancer with disease progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving CYRAMZA. (1.2)
in combination with FOLFIRI, for the treatment of metastatic colorectal cancer with disease progression on or after prior therapy with bevacizumab, oxaliplatin, and a fluoropyrimidine. (1.3)
DOSAGE AND ADMINISTRATION
For intravenous infusion only. Do not administer as an intravenous push or bolus. (2)
Gastric Cancer
The recommended dose of CYRAMZA either as a single agent or in combination with weekly paclitaxel is 8 mg/kg every 2 weeks. (2.1, 2.2, 2.3)
Non-Small Cell Lung Cancer
Administer CYRAMZA at 10 mg/kg intravenously on day 1 of a 21-day cycle prior to docetaxel infusion. (2.1, 2.2, 2.3)
Colorectal Cancer
Administer CYRAMZA at 8 mg/kg intravenously every 2 weeks, prior to FOLFIRI administration. (2.1, 2.2, 2.3)
DOSAGE FORMS AND STRENGTHS
Injection:
100 mg/10 mL (10 mg per mL) solution, single-dose vial (3)
500 mg/50 mL (10 mg per mL) solutio |
