2015年10月23日，美国FDA批准Onivyde（伊立替康脂质体注射液）与氟尿嘧啶和亚叶酸联用用于治疗既往接受过吉西他滨化疗的晚期转移性胰腺癌患者。
据美国国立癌症研究所估计，2015年美国胰腺癌新确诊患者将达48,960例，胰腺癌死亡病例也达40,560例。胰腺癌早期诊断困难且治疗选择有限，特别是对于已经转移至身体其他部位（转移性）的胰腺癌患者，不能进行手术切除治疗。
FDA药品评价与研究中心血液与抗肿瘤产品办公室主任Richard Pazdur博士指出：“FDA许多新药审评专家也是临床医生，每当我们能够加速批准可用于尚未得到治疗满足需求患者的新药时，感觉特别有益。Onivyde通过优先审评获批，患者可早日得到这一药物治疗，有助于延长生存时间。”
FDA授予Onivyde优先审评和孤儿药资格认定。优先审评资格是授予那些一旦获批，可显著改善严重疾病治疗药物安全性和有效性的新药申请。孤儿药资格认定则通过税额抵免、消费者付费豁免、市场独占权等激励政策，扶持和鼓励罕见病治疗药物的开发。
Onivyde的有效性在一项三臂、随机、开放研究中得到证实。该研究纳入417例曾接受吉西他滨或以吉西他滨为基础化疗但未得到控制的转移性胰腺癌患者，旨在比较Onivyde+氟尿嘧啶/亚叶酸治疗或Onivyde单纯治疗患者生存期是否大于氟尿嘧啶/亚叶酸治疗患者。Onivyde+氟尿嘧啶/亚叶酸治疗患者平均生存期为6.1个月，而氟尿嘧啶/亚叶酸治疗患者为4.2个月。与氟尿嘧啶/亚叶酸治疗患者相比，单纯Onivyde治疗患者生存期未见改善。
此外，Onivyde+氟尿嘧啶/亚叶酸治疗患者肿瘤增长开始时间延迟，这些治疗患者肿瘤增长开始时间为3.1个月，而氟尿嘧啶/亚叶酸治疗患者为1.5个月。
通过398例Onivyde+氟尿嘧啶/亚叶酸治疗、Onivyde单纯治疗或氟尿嘧啶/亚叶酸治疗患者对Onivyde的安全性进行了评价。Onivyde治疗最常见副作用包括腹泻、乏力、呕吐、恶心、食欲下降、口腔感染（口腔炎）以及发热。Onivyde治疗还可导致抗感染细胞下降（淋巴细胞减少症和中性白细胞减少症），还有报告Onivyde治疗患者因中性白细胞减少症继发脓毒血症死亡病例。
Onivyde说明书中包含了一项有关严重嗜中性白细胞减少症和腹泻风险的黑框警告。Onivyde没有获准可单独用于转移性胰腺癌患者治疗。
Onivyde由马塞诸萨州剑桥市Merrimack制药公司上市销售

Onivyde Approval History
•FDA approved: Yes (First approved October 22nd, 2015)
•Brand name: Onivyde
•Generic name: irinotecan liposomal
•Previous name: MM-398
•Company: Merrimack Pharmaceuticals, Inc.
•Treatment for: Pancreatic Cancer
Onivyde (irinotecan liposome injection) is a liposomal formulation of the topoisomerase I inhibitor irinotecan indicated for the treatment of post-gemcitabine metastatic adenocarcinoma of the pancreas.
FDA Approval: The effectiveness of Onivyde was demonstrated in a study of 417 patients with metastatic pancreatic adenocarcinoma whose cancer had progressed following gemcitabine-based therapy. Patients treated with Onivyde plus fluorouracil/leucovorin lived an average of 6.1 months, compared to 4.2 months for those treated with only fluorouracil/leucovorin.
Mechanism: Onivyde is a novel encapsulation of irinotecan in a liposomal formulation. SN-38, the active metabolite of irinotecan, inhibits topoisomerase I (an essential enzyme involved in DNA transcription and replication) and promotes cell death.
Administration: Onivyde is administered by intravenous infusion over 90 minutes every 2 weeks, prior to leucovorin and fluorouracil. Onivyde is not approved for use as a single agent.
Side Effects: Common side effects reported in clinical trials included diarrhea, fatigue, vomiting, nausea, decreased appetite, inflammation in the mouth (stomatitis) and fever (pyrexia). Onivyde was also found to cause lymphopenia and neutropenia.
Additional Information: The labeling for Onivyde includes a boxed warning to alert health care professionals about the risks of potentially life-threatening neutropenia and severe diarrhea. Onivyde may cause severe hypersensitivity reactions including anaphylactic reactions. Onivyde can cause fetal harm when administered to a pregnant woman, so females of reproductive potential should use effective contraception at all times during treatment, and for one month after the final dose. Males with female partners of reproductive potential should use effective contraception at all times during treatment, and for four months after the final dose. Nursing women should not breastfeed at any time during treatment, and for one month after the final dose.