Generic Name and Formulations:
Ramucirumab 10mg/mL; per vial; soln for IV infusion after dilution; preservative-free.

Company:
Lilly, Eli and Company
Indications for CYRAMZA:
As a single agent, or in combination with paclitaxel, for treatment of advanced or metastatic, gastric or gastro-esophageal junction adenocarcinoma with disease progression on or after prior fluoropyrimidine- or platinum-containing chemotherapy. In combination with FOLFIRI (irinotecan, folinic acid, and 5-fluorouracil), for the treatment of metastatic colorectal cancer (mCRC) with disease progression on or after prior therapy with bevacizumab, oxaliplatin, and a fluoropyrimidine.

Adult:
Give by IV infusion over 60 mins. Premedicate with IV histamine H1-antagonist (eg, diphenhydramine) prior to each infusion; or with dexamethasone and acetaminophen in those who have experienced Grade 1 or 2 infusion reaction. Gastric cancer: 8mg/kg every 2 weeks. When given in combination: administer prior to paclitaxel. mCRC: 8mg/kg every 2 weeks prior to FOLFIRI. Continue until disease progression or unacceptable toxicity. Dose modifications: see full labeling.

Children:
Not established.

Warnings/Precautions:
Increased risk of hemorrhage; permanently discontinue if severe bleeding occurs. Control hypertension prior to initiating. Monitor blood pressure every 2 weeks or more frequently as indicated; if severe hypertension develops, temporarily suspend until medically controlled. Monitor for infusion-related reactions during therapy. Have emergency resuscitative equipment available. Permanently discontinue if severe arterial thromboembolic events, severe uncontrolled hypertension (despite antihypertensives), hypertensive crisis or encephalopathy, Grade 3 or 4 infusion-related reactions, urine protein >3g/24hrs, nephrotic syndrome, or GI perforation occurs. Impaired wound healing: withhold Cyramza prior to surgery. Clinical deterioration in patients with Child-Pugh B or C cirrhosis (eg, new or worsening encephalopathy, ascites, hepatorenal syndrome). Discontinue if reversible posterior leukoencephalopathy syndrome develops. Monitor proteinuria by urine dipstick and/or urinary protein creatinine ratio. Monitor thyroid function. Pregnancy: avoid. Use effective contraception during therapy and for ≥3 months after last ramucirumab dose. Nursing mothers: not recommended.

Pharmacological Class:
Human IgG1 monoclonal antibody.

Adverse Reactions:
Hypertension, diarrhea, headache, fatigue, asthenia, hyponatremia, anemia, intestinal obstruction, neutropenia, epistaxis, stomatitis/mucosal inflammation, rash, decreased appetite; arterial thromboembolic events, proteinuria, GI perforation, infusion-related reactions.

How Supplied:
Single-dose vial (10mL, 50mL)—1
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