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欧洲批准Rolapitant用于预防成人癌症化疗相关性呕吐

2017-05-23 13:39:45 作者：新特药房来源：互联网浏览次数：0 文字大小：【大】【中】【小】

简介： 近日，欧盟委员会(EC)批准癌症药物开发的生物公司Tesaro表示Varuby®(Oral Rolapitant 罗拉吡坦片)用于成人癌症患者的化疗所致的迟发性恶心和呕吐的预防。化疗相关性呕吐(CINV)是一种发生频率高、致人 ...

关键字：罗拉吡坦片 Oral Rolapitant商品名Varuby® 用于预防癌症化疗相关性呕吐

近日，欧盟委员会(EC)批准癌症药物开发的生物公司Tesaro表示Varuby®(Oral Rolapitant 罗拉吡坦片)用于成人癌症患者的化疗所致的迟发性恶心和呕吐的预防。
化疗相关性呕吐(CINV)是一种发生频率高、致人虚弱的可预防的化疗副作用。出现呕吐症状的原因是化疗导致患者体内释放一种称为p物质(Substance P，SP)的神经肽，这种神经肽与大脑中呕吐中枢的神经细胞上的神经激肽-1(Neurokinin-1，NK-1)受体相结合会导致患者产生恶心和呕吐的症状。
Rolapitant是一种口服的长效NK-1拮抗剂，通过阻断NK-1与SP的结合，可以改善接受化疗患者的呕吐症状，具有吸收快、清除慢的特点，血浆半衰期达7天。在每个化疗周期开始前的2个小时内服用180mg(两片)Varuby(最短间隔时间为两周)，作为组合疗法的一部分。Varuby的3组临床3期研究已经证实，对于接受致吐化疗(卡铂、顺铂、蒽环类/环磷酰胺)的患者，服用Rolapitant可以显著降低呕吐的发作。同时，接受Varuby治疗的患者，影响患者正常生活的恶心症状也更低，多个周期化疗的呕吐发作率也更小。所有临床试验结果发表在2015年8月份的The Lancet Oncology。
Tesaro公司总经理及高级副总裁Orlando Oliveira 表示：“有一般接受致吐化疗的癌症患者会出现恶心和呕吐的症状，Varuby在欧洲的上市，将让临床医生拥有预防这种化疗副作用的新选择。Varuby的欧洲上市，是Tesaro公司国际化进程的里程碑事件，Tesaro在17个欧洲国家拥有业务单元，我们非常期待Varuby可以尽快用于欧洲的癌症患者。”
法国巴黎Hospital Europesen Georges Pompidou肿瘤医学部门的Florian Scotté博士表示：“虽然化疗相关性呕吐的临床治疗已经有了较大的发展，但是恶心和呕吐仍然是接受化疗治疗的癌症患者最严重和最常发生的两种副作用。接受Varuby这样的NK-1受体拮抗剂的治疗，可以达到7天之久的半衰期，可以覆盖大脑皮质区的90%的受体并持续5天之久，可以显著降低化疗相关性呕吐的发生并控制数天。
这次上市申请属于集中审评，适用于所有的28个欧盟成员国以及欧洲经济区国家冰岛、利希滕施泰因和挪威。目前，Tesaro正忙于同欧洲各国家的医保机构进行协商以确保该药物可以让更多的患者受益。
罗拉吡坦片已在2015年9月1日获得美国FDA批准，上市商品名则为Varubi®。
TESARO Announces Approval of VARUBY® (Oral Rolapitant Tablets) by European Commission
•VARUBY provides protection for delayed chemotherapy-induced nausea and vomiting (CINV) with a single dose as part of an antiemetic regimen
•Up to 50% of patients undergoing highly or moderately emetogenic chemotherapy experience delayed CINV even when prescribed a 5-HT3 receptor antagonist and corticosteroid
•Approval based upon results of three Phase 3 trials of patients receiving emetogenic chemotherapy, including cisplatin, carboplatin and anthracycline/cyclophosphamide-based regimens
•Commercial launches to begin on a country-by-country basis in Europe by end of Q2
26, 2017 (GLOBE NEWSWIRE) -- TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical company, today announced that the European Commission (EC) has approved VARUBY® (oral rolapitant tablets) for the prevention of delayed nausea and vomiting associated with highly and moderately emetogenic cancer chemotherapy in adults. Chemotherapy-induced nausea and vomiting (CINV) is a frequent and debilitating, yet often preventable, side effect of chemotherapy.
VARUBY is a selective and competitive antagonist of human substance P/neurokinin 1 (NK-1) receptors that is rapidly absorbed and slowly eliminated, with a plasma half-life of seven days. A single 180 milligram dose (two tablets) of VARUBY is to be administered within two hours prior to initiation of each chemotherapy cycle, but at no less than 2‑week intervals, as part of combination therapy. Results from three global Phase 3 trials of VARUBY demonstrated a significant reduction in episodes of vomiting or use of rescue medication during the 25 to 120 hour period following administration of emetogenic chemotherapy, including cisplatin, carboplatin and anthracycline/cyclophosphamide-based regimens. In addition, patients who received VARUBY reported experiencing less nausea that interfered with normal daily life and fewer episodes of vomiting over multiple cycles of chemotherapy. Results of each of the three Phase 3 studies were published in The Lancet Oncology in August 2015.
“With more than half of patients treated with emetogenic chemotherapy experiencing delayed nausea and vomiting, the approval of VARUBY will give physicians in Europe a new option to help prevent this serious side effect,” said Orlando Oliveira, Senior Vice President and General Manager of TESARO International. “This approval represents an important milestone in TESARO’s international expansion. With TESARO operating in European countries, we look forward to bringing this important medicine to patients as quickly as possible.”
“While important progress in the treatment and prevention of delayed CINV has been made, nausea and vomiting continue to be two of the most common and distressing side effects of cancer chemotherapy,” said Florian Scotté, M.D., Ph.D., Head of the Functional Unit of Supportive Care, Department of Medical Oncology at Hôpital Européen Georges Pompidou, Paris, France. “Adding an NK-1 receptor antagonist such as VARUBY, which has a 7-day half-life and greater than 90% receptor occupancy in the cortical regions of the brain five days after dosing, can provide enhanced protection from delayed CINV, which can last for several days.”
The centralised marketing authorisation applies to all 28 European Union (EU) member states as well as in the European Economic Area (EEA) countries of Iceland, Lichtenstein and Norway. TESARO is working with the appropriate national authorities in the European countries to support reimbursement and availability of VARUBY to ensure that patients who may benefit from VARUBY have access to it.
Oral rolapitant was approved by the U.S. Food and Drug Administration on September 1, 2015 and is marketed by TESARO in the United States under the brand name VARUBI®.
About Chemotherapy-Induced Nausea and Vomiting (CINV)
Chemotherapy-induced nausea and vomiting is a debilitating, yet often preventable, side effect of chemotherapy. Up to 50% of patients undergoing highly or moderately emetogenic chemotherapy experience delayed CINV (>24 to 120 hours post chemotherapy)—even when prescribed a 5-HT3 receptor antagonist and a corticosteroid. Blocking both 5-HT3 and NK-1 receptors has been shown to offer better control of nausea and vomiting than inhibiting 5-HT3 receptors alone. Adding a single dose of VARUBY® to an antiemetic regimen, including a 5-HT3 receptor antagonist and corticosteroid, within two hours prior to each chemotherapy cycle as part of combination therapy further improves prevention of delayed CINV.
About the VARUBY (Oral Rolapitant Tablets) Clinical Program
The efficacy of VARUBY was established in multiple randomized, well-controlled, international, blinded clinical trials that enrolled more than 2,500 patients. VARUBY, when administered in combination with a 5-HT3 receptor antagonist and dexamethasone, was superior to a 5-HT3 receptor antagonist and dexamethasone in preventing CINV in patients receiving either moderately or highly emetogenic chemotherapy.
The clinical profile of VARUBY in cisplatin-based highly emetogenic chemotherapy (HEC) was confirmed in two identical Phase 3 studies: HEC1 and HEC2. Both trials met their primary endpoint of complete response (CR), and demonstrated statistical superiority of rolapitant 180 mg compared to active control (5-HT3 receptor antagonist plus dexamethasone) in the delayed phase (25-120 hours) of CINV. In HEC1, 264 patients received rolapitant 180 mg and 262 received control. The proportion of patients achieving a CR was 72.7% vs. 58.4% (p=< 0.001). In HEC2, 271 patients received rolapitant and 273 received control. The proportion of patients achieving a CR was 70.1% vs. 61.9% (p=0.043). The most common adverse reactions (≥3%) among patients receiving cisplatin-based chemotherapy were neutropenia (9% rolapitant vs. 8% control), hiccups (5% vs. 4%), and abdominal pain (3% vs. 2%).
A Phase 3 trial was also conducted to evaluate rolapitant 180 mg compared to active control in 1,332 patients receiving moderately emetogenic chemotherapy regimens, including anthracycline/cyclophosphamide combinations, carboplatin, irinotecan, pemetrexed, oxaliplatin, and doxorubicin. This trial met its primary endpoint of CR, and demonstrated statistical superiority of rolapitant 180 mg compared to active control (5-HT3 receptor antagonist plus dexamethasone) in the delayed phase of CINV. The proportion of patients achieving a CR was 71.3% vs 61.6% (p= < 0.001). The most common adverse reactions (≥3%) among patients receiving these chemotherapies were decreased appetite (9% rolapitant vs. 7% control), neutropenia (7% vs. 6%), dizziness (6% vs. 4%), dyspepsia (4% vs. 2%), urinary tract infection (4% vs. 3%), stomatitis (4% vs. 2%), and anemia (3% vs. 2%).
About VARUBY® (oral rolapitant tablets)
VARUBY is a substance P/neurokinin-1 (NK-1) receptor antagonist that is approved in the European Union for use in combination with other antiemetic agents in adults for the prevention of delayed nausea and vomiting associated with highly and moderately emetogenic cancer chemotherapy in adults. VARUBY is contraindicated in combination with St John’s wort. Each tablet contains 90 mg of rolapitant (as hydrochloride monohydrate). The inhibitory effect of a single dose of VARUBI/VARUBY on CYP2D6 lasts at least seven days and may last longer. VARUBI/VARUBY is not recommended in patients who require chronic administration of strong or moderate enzyme inducers. Please see full product information for more details.