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美国FDA批准Alecensa(alectinib)为肺癌治疗新药

2015-12-13 05:34:54 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： 2015年12月11日，美国食品和药品监管局(FDA)批准Alecensa (alectinib)治疗有晚期(转移) ALK-阳性非小细胞肺癌(NSCLC)其疾病已恶化后，或不能耐受治疗，另一种治疗被称为Xalkori (克里唑蒂尼[crizotinib]) ...

关键字：alectinib 商品名alecensaalk 阳性小细胞肺癌突破性治疗优先审评加快审批孤儿药物

2015年12月11日，美国食品和药品监管局(FDA)批准Alecensa (alectinib)治疗有晚期(转移) ALK-阳性非小细胞肺癌(NSCLC)其疾病已恶化后，或不能耐受治疗，另一种治疗被称为Xalkori (克里唑蒂尼[crizotinib])人们。
按照美国国立癌症研究所肺癌是美国癌症死亡主要原因，2015年估计221,200新诊断和 158,040死亡。一个ALK (间变性淋巴瘤激酶)基因突变可能发生在几种不同类型癌细胞，包括肺癌细胞。ALK基因突变是存在于约5 %有 NSCLC患者，在转移癌中，疾病播散至机体新部位。在ALK-阳性NSCLC转移患者，脑是疾病播散常见位置。
FDA的药品评价和研究中心中血液学和肿瘤学主任Richard Pazdur，M.D.说：“今天的批准为一组患者一旦他们的疾病用Xalkori治疗不再响应提供一种新治疗选择，” “Alecensa临床试验提供证据除了对在肺中肿瘤主要作用外，对已播散至脑肿瘤作用，这是对临床医生要了解的重要效应。”
Alecensa是一种口服药物它阻断ALK蛋白的活性，可能预防NSCLC细胞生长和播散。
在疾病不再被用Xalkor治疗控制的有转移ALK-阳性NSCLC患者两项单臂临床试验研究Alecensa的安全性和疗效。研究参加者接受Alecensa每天2次测定药物对他们的肺癌肿瘤的效应。在第一项研究中，38 %参加者经历他们的NSCLC 肿瘤部分皱缩，一种效应持续共平均7.5个月。在第二项研究中，44 %参加者经历他们的NSCLC肿瘤的部分皱缩，持续共平均11.2个月，试验还检查Alecensa对个体脑转移的影响，在这个人群常发生。在两项试验61%参加者有可测量的脑转移经历在他们的脑肿瘤中一个完全或部分缩小，持续平均9.1个月。
Alecensa 的最常见副作用是疲乏，便秘，肿胀(水肿)和肌痛。Alecensa可能致严重副作用，包括肝脏问题，严重或威胁生命肺的炎症，非常缓慢的心跳和严重肌肉问题。用Alecensa治疗可能致晒伤当患者被暴露至阳光。
Alecensa用加快审批监管途径被批准，这让FDA批准对严重或威胁生命疾病产品根据证据产品对结局有一种影响，是有可能合理预测临床获益。在Alecensa的情况中，肿瘤响应治疗，与响应时间在一起，提供这个证据。在加快审批要求下，要求一个验证性研究证实和描述Alecensa的临床获益。
FDA授予Alecensa申请突破性治疗指定和优先审评状态。这些是鉴于有严重或威胁生命情况患者其潜在的获益不同程序意向促进和加快某些新药开发和审评。 Alecensa还接受孤儿药物指定，它提供奖励例如税收减免，用户收费减免和对专有权资格，有助和鼓励对罕见疾病药物开发。
Alecensa由总部在加州旧金山的Genentech上市。Xalkori由总部纽约州纽约的is marketed by Pfizer上市。
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm476926.htm
http://www.kegg.jp/medicus-bin/japic_med_product?id=00063143
New Drugs Online Report for alectinib
Information
Generic Name: alectinib
Trade Name: Alecensa
Synonym: RO5424802, CH5424802
Entry Type: New molecular entity
Development and Regulatory status
UK: Pre-registration (Filed)
EU: Pre-registration (Filed)
US: Pre-registration (Filed)
UK launch Plans: Available only to registered users
Actual UK launch date:
Comments
Oct 15: Filed in EU [7].
02/11/2015 12:46:36
Sept 15: Genentech announced that the US FDA accepted their New Drug Application (NDA) and granted Priority Review for alectinib for the treatment of people with ALK-positive, locally advanced or metastatic NSCLC who have progressed on or are intolerant to crizotinib. The NDA for alectinib includes data from two PII studies (NP28761 and NP28673), and the FDA will make a decision on approval by March 4, 2016 [5].
10/09/2015 09:28:47
Apr 15: EU & US filings in second-line ALK-positive NSCLC planned for 2015 [4].
15/06/2015 16:17:45
Feb 15: filing outside Japan anticipated 2016 or beyond [3]
27/02/2015 13:32:29
Sep 14: launched in Japan [3]
27/02/2015 13:30:02
Sep 13: Awarded breakthrough therapy by the FDA [1].
24/09/2013 08:38:30
Trial or other data
Sep 15: The US priority review is based on results from two PII studies: the NP28761 trial showed an objective response rate of 47.8% in patients taking alectinib and a median response of 7.5 months, while the NP28673 study showed an ORR of 50% and a median response of 11.2 months [6].
11/09/2015 12:01:09
NCT01801111 is an open-label, non-randomized, multicenter PI/II study evaluating RO5424802 in 130 patients with NSCLC who have ALK mutation and failed crizotinib treatment. In Part 1, patients will receive escalating doses of RO5424802 twice daily. In Part 2, patients will receive the recommended PII dose as determined in Part 1. Treatment will continue in Part 1 and Part 2 on the same dose until disease progression. In Part 3, following disease progression, patients without EGFR mutation will be offered continued treatment with RO5424802, patients with EGFR mutations will be offered a combination of RO5424802 and erlotinib. The study started in Jun 13 and is due to complete Oct 15 [2].
24/09/2013 08:58:27
NCT01871805 is a PI/II non-randomized, open-label, multicenter study evaluating CH5424802/RO5424802 in 85 patients with ALK-rearranged NSCLC who failed crizotinib treatment. In PI, patients will receive escalating doses twice daily. In PII, patients who failed crizotinib and at least one line of platinum-based chemotherapy treatment will receive the recommended PII dose (as determined in PI). The study started Aug 13 and is due to complete Jul 15 [2].
24/09/2013 08:58:19
NCT01588028 is an open label, non-randomized P1/II evaluating RO5424802 in 36 patients with NSCLC who have ALK mutation and have failed crizotinib therapy. PI will to determine: dose limiting toxicity, the maximum tolerated dose, pharmacokinetic parameters and the recommended dose. In PII CH5424802 will be assessed at the recommended dose. The study started in Apr 12 and is due to complete Sep 14 [2].
24/09/2013 08:58:12
Evidence Based Evaluations
NIHR HSRIC http://www.hsric.nihr.ac.uk/topics/alectinib-for-locally-advanced-or-metastatic-alk-positive-non-small-cell-lung-cancer-following-failure-of-crizotinib/
References
Available only to registered users
Category
BNF Category: Other antineoplastic drugs (08.01.05)
Pharmacology: ALK inhibitor
Epidemiology: More than 39,000 new cases of lung cancer are diagnosed in the UK each year. NSCLC accounts for 85% of cases.
Indication: Non-small cell lung cancer (NSCLC)
Additional Details: ALK-positive, after failed crizotinib treatment
Method(s) of Administration
Oral
Company Information
Name: Roche
US Name: Roche
Further Information
Anticipated commissioning route (England) NHSE
High cost drug list? Awaiting Update
Implications Available only to registered users