By：好医友（HAOEYOU）
Today the U.S. Food and Drug Administration expanded the approved use of Yervoy (ipilimumab) to include a new use as adjuvant therapy for patients with stage III melanoma, to lower the risk that the melanoma will return following surgery.
2015年10月28日美国食品和药品监管局扩展批准使用Yervoy(普利姆玛[ipilimumab])包括一种新使用作为辅助治疗对有III期黑色素瘤患者，以降低手术后黑色素瘤返回风险。
Melanoma, the most aggressive type of skin cancer, is the leading cause of death from skin cancer. Melanoma is more likely to spread to other parts of the body than other forms of skin cancer and has been on the rise over the past several decades, according to the National Cancer Institute, with an estimated 73,870 new cases and 9,940 deaths from the disease this year. In stage III melanoma, the cancer has reached one or more lymph nodes. Patients with stage III melanoma are generally treated by surgery to remove the melanoma skin lesions and the nearby lymph nodes.
黑色素瘤，皮肤癌的最进取型，是皮肤癌死亡的领先原因。黑色素瘤比其他形式皮肤癌更可能播散至机体的其他部分和过去几十年以上升，按照美国癌症研究所，本年估算73,870新病例和9,940死于此病。III期黑色素瘤中，癌症已到达一个或更多淋巴结。有III期黑色素瘤患者一般地通过手术去除黑色素瘤皮肤病变和临近淋巴结治疗。
“Today’s approval of Yervoy extends its use to patients who are at high risk of developing recurrence of melanoma after surgery,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in FDA’s Center for Drug Evaluation and Research. “This new use of the drug in earlier stages of the disease builds on our understanding of the immune system’s interaction with cancer.”
FDA的药品评价和研究中心中血液学和肿瘤室主任Richard Pazdur，M.D.说：“ Yervoy今天的批准扩展其使用至手术后黑色素瘤处于高风险发生复发的，” “在疾病较早期这个药物的新使用建立在我们对免疫系统与癌症相互作用了解。”
Yervoy, administered intravenously, was originally approved in 2011 to treat late-stage melanoma that cannot be removed by surgery. Yervoy is a monoclonal antibody that blocks a molecule known as CTLA-4 (cytotoxic T-lymphocyte antigen). CTLA-4 may play a role in slowing down or turning off the body’s immune system, and affects its ability to fight off cancerous cells. Yervoy may work by allowing the body’s immune system to recognize, target and attack cells in melanoma tumors.
在2011年Yervoy，静脉给药，原来被批准治疗不能手术去除的晚期黑色素瘤。Yervoy是一个单克隆抗体阻断一个分子被称为CTLA-4(细胞毒T-淋巴细胞抗原)。CTLA-4在减缓或关闭机体免疫系统中可能起作用，和影响其击退癌细胞的能力。Yervoy可能通过允许机体免疫系统识别，靶向和攻击黑色素瘤肿瘤中细胞作用。
The safety and effectiveness of Yervoy for this new use were studied in 951 patients who received Yervoy or a placebo as adjuvant therapy following complete surgical removal of melanoma. The study measured the amount of time after treatment it took for the cancer to come back (“recurrence-free survival”) and overall survival. Forty-nine percent of participants taking Yervoy had their cancer return after an average of 26 months, compared to 62 percent of those receiving a placebo, whose cancer returned after an average of 17 months. The analysis of overall survival data has not yet occurred.
在951例患者完成手术去除黑色素瘤后接受Yervoy或一种安慰剂作为辅助治疗，研究Yervoy对这个新使用的安全性和有效性。研究测定治疗后肿瘤返回所需时间量(“无复发生存”)和总体生存。用Yervoy参加者49%有癌症返回，平均26个月后，与之比较，接受一种安慰剂参加者为62%，平均17个月后。尚无总体数据生存分析。
The most common side effects of Yervoy in this study were rash, diarrhea, fatigue, itching, headache, weight loss and nausea. Yervoy can also cause autoimmune disease in the digestive system, liver, skin, nervous system (which would each require treatment with corticosteroids), as well as in the hormone-producing glands (which requires life-long hormone replacement therapy). Women who are pregnant should not take Yervoy because it may cause harm to a developing fetus.
在这个研究中Yervoy的最常见副作用是皮疹，腹泻，疲乏，痒，头痛，体重减轻和恶心。Yervoy还可能在消化系统，肝，皮肤，神经系统中致自身免疫疾病(这将每个需要皮质激素治疗)，以及在激素-产生腺体(这需要终生激素替代疗法)。妊娠妇女不应用Yervoy因为它可能致发育中胎儿危害。
Due to the potential for fatal immune-mediated adverse reactions and unusual severe side effects with Yervoy, the label includes a Boxed Warning. A Medication Guide will also be provided to patients to inform them about the therapy's potential side effects.
由于用Yervoy对致命性免疫-介导不良反应和不寻常严重副作用潜能，说明书包括一个黑框警告。还将对患者提供一个用药指南告知他们关于治疗的潜在副作用。
