2014年10月10日美国食品和药品监督管理局(FDA)批准Akynzeo(netupitant和帕诺斯琼[palonosetron])治疗进行癌症化疗患者中的恶心和呕吐。
Akynzeo是由两种药物固定组合组成的胶囊。口服帕诺斯琼在2008年批准预防癌症化疗开始后急性相期间(头24小时内)的恶心和呕吐。Netupitant，一种新药，预防癌症化疗开始后急性相和延迟相二者期间(从25至120小时)的恶心和呕吐。
FDA药品评价和研究中心药物评价III室主任Julie Beitz，医学博士说：“支持医护产品，例如Akynzeo，有助于缓解患者可能经受恶心和呕吐作为癌症化疗的副作用。”
在两项1,720例接受癌症化疗参加者临床试验Akynzeo的有效性。参加者被随机赋予接受 Akynzeo或口服帕诺斯琼。试验被设计测量研究药物是否预防癌症化疗开始后在急性，延迟和总体相任何呕吐发作。
头一项试验结果显示在急性，延迟和总体相期间分别98.5 %，90.4 %和89.6 % 的Akynzeo-治疗参加者不经历任何呕吐或需要对恶心抢救药物。相反，用口服帕诺斯琼治疗参加者急性，延迟和总体相期间分别有89.7 %，80.1 %和76.5 %不经历任何呕吐或需要对恶心抢救药物。第二个试验显示相似结果。
在临床试验中Akynzeo的常见副作用是头痛，软弱(无力)，疲乏，消化不良和便秘。.
在总部瑞士的Helsinn Healthcare S.A许可下，新泽西州Woodcliff Lake的Eisai公司分配和上市.Akynzeo。
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm418375.htm
The Food and Drug Administration (FDA) has approved Akynzeo (netupitant and palonosetron; Eisai) to treat nausea and vomiting in patients undergoing cancer chemotherapy. Akynzeo is a fixed-dose combination capsule consisting of oral palonosetron, which prevents nausea and vomiting during the acute phase (within the first 24 hours) after the start of cancer chemotherapy and netupitant, which prevents nausea and vomiting during both the acute phase and delayed phase (from 25–120 hours) after the start of cancer chemotherapy.
The effectiveness of Akynzeo was established in two clinical trials with 1,720 participants receiving cancer chemotherapy. Participants were randomized to receive Akynzeo or oral palonosetron. The trials were designed to measure whether the study drugs prevented any vomiting episodes in the acute, delayed and overall phases after the start of cancer chemotherapy.
RELATED: Antiemetic Treatments
Results of the first trial demonstrated that 98.5%, 90.4% and 89.6% of Akynzeo-treated participants did not experience any vomiting or require rescue medication for nausea during the acute, delayed and overall phases, respectively. In contrast, 89.7%, 80.1% and 76.5% of participants treated with oral palonosetron did not experience any vomiting or require rescue medication for nausea during the acute, delayed and overall phases, respectively. The second trial showed similar results.
Akynzeo will be available as 300mg netupitant/0.5mg palonosetron strength gelatin coated capsules.