2015年7月24日 -美国食品和药物管理局今天批准Odomzo（sonidegib）治疗的患者已经复发手术或放射治疗，或谁是不适合手术或放射治疗局部晚期基底细胞癌。
皮肤癌是最常见的癌和基底细胞癌占大约80％的非黑素瘤皮肤癌。基底细胞癌开始于皮肤的顶层（称为表皮），通常在已经经常暴露在阳光和其它形式的紫外线辐射的区域发展。据美国国家癌症研究所，出现的非黑色素瘤皮肤癌的新发病例数每年都在增加。局部晚期基底细胞皮肤癌是指还没有扩散到身体的其他部位基底癌症，但不能与局部治疗，特别是手术和放射来治疗性治疗。
Odomzo是一天服用一次一丸。它的工作原理是通过抑制的分子途径，被称为Hedgehog通路，这是活跃在基底细胞癌。通过抑制该途径，Odomzo可能停止或减少癌病变的生长。
“我们越来越多参与癌症分子通路的认识，导致了许多肿瘤药物为其中一些治疗方法以前就存在难以治疗疾病的批准，”理查德Pazdur博士，医学博士，血液学和肿瘤学产品办公室主任中说FDA的药品评价中心和研究。“多亏了更好地了解Hedgehog通路中，FDA已经批准了现在两种药物基底细胞癌的治疗只是在过去的三年。”在2012年，Erivedge（vismodegib）被批准用于治疗局部晚期的第一个药物和转移性基底细胞癌。
Odomzo带有黑框警告提醒医疗专业人员当给予孕妇的Odomzo可能会导致发育中的胎儿死亡或严重出生缺陷。怀孕状况应Odomzo治疗开始前验证，男性和女性患者，应警告这些风险，并建议使用有效的避孕方法。
Odomzo的功效成立于一项多中心，双盲临床试验，其中66例局部晚期基底细胞癌患者随机分配到200毫克，每日接收Odomzo和128名患者被分配每天服用800 Odomzo毫克。该研究的主要终点是客观缓解率，这是谁经历局部收缩或他们的肿瘤（S）完全消失的患者百分比。结果表明，与Odomzo 200毫克治疗的患者58％有他们的肿瘤缩小或消失。这种效果持续了至少1.9至18.6个月，约一半的反应的患者“肿瘤缩小的历时半年或更长时间。反应率谁收到Odomzo 800毫克，每天的病人相似，但副作用是比较常见的，在这个剂量。
在200毫克，每日一剂，Odomzo的最常见的副作用是肌肉痉挛，脱发（脱发），味觉障碍（失真味觉），乏力，恶心，肌肉骨骼痛，腹泻，体重下降，食欲下降，肌痛（肌肉疼痛），腹痛，头痛，疼痛，呕吐，皮肤瘙痒（痒）。Odomzo也有可能造成严重的肌肉骨骼相关的副作用，包括增加的血清肌酸激酶水平[与肌肉组织分解罕见报告（横纹肌溶解）]，肌肉痉挛，和肌痛的潜力。
Odomzo由东汉诺威，新泽西州的诺华制药公司销售。Erivedge由Genentech公司在旧金山，加利福尼亚州销售。
New Drugs Online Report for sonidegib
Information
Generic Name: sonidegib
Trade Name: Odomzo
Synonym: LDE225, erismodegib
Entry Type: Licence extension / variation
Development and Regulatory status
UK: Phase II Clinical Trials
EU: Phase II Clinical Trials
US: Phase II Clinical Trials
UK launch Plans: Available only to registered users
Actual UK launch date:
Comments
Mar 15: Not in company filings Jan2015 list [5]
27/03/2015 16:33:14
Mar 14: Planned filing for >2018 [3]
12/03/2014 16:14:46
Trial or other data
Oct 15: PII (NCT01708174) study has completed recruitment; due to complete Dec 15 [7].
12/01/2016 17:28:25
Mar 15: NCT01708174 is now listed as a PII study only with a completion date of Mar 15 [6].
27/03/2015 16:34:17
Jul 13: NCT01708174 is a PIII, multi-center, open-label, randomized, controlled study of oral erismodegib vs temozolomide (TMZ) in 109 adults and children with Hedge-Hog (Hh)-pathway activated relapsed medulloblastoma. The study allows the eva luation in 2 separate subgroups: in children ≤ 6 years of age who may or may not have previously been treated with TMZ but who have not received prior radiotherapy and in adult and children who may have received prior radiotherapy and TMZ. The primary outcome is overall response rate (ORR) at 8 weeks. The study started in May 13 and is due to complete Nov 16 [1].
26/07/2013 18:45:18
References
Available only to registered users
Category
BNF Category: Other antineoplastic drugs (08.01.05)
Pharmacology: Smoothened (Smo) protein antagonist. Smo is a G protein-coupled receptor-like molecule that is essential to the actions of the Hedgehog family of secreted proteins.
Epidemiology: Mar 14: It has been estimated that the lifetime risk of developing brain and other central nervous system (CNS) cancer is 1 in 133 for men and 1 in 185 for women in the UK. The incidence of brain and CNS tumours in the UK in 2007 was 6.8 per 100,000 (male 8.1 per 100,000 and female 5.6 per 100,000). [4]
Indication: Brain cancer
Additional Details: medulloblastoma, relapsed Hh-pathway activated
Method(s) of Administration
Oral
Company Information
Name: Novartis
US Name: Novartis
Further Information
Anticipated commissioning route (England) NHSE
High cost drug list? Awaiting Update
Implications Available only to registered users
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