抗癌药ODOMZO(SONIDEGIB PHOSPHATE 中文译名：索尼得吉)胶囊-获FDA加速批准用于基底细胞癌成人患者的治疗口服
Odomzo（sonidegib）用于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。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。
FDA的药品评价和研究中心血液学和肿瘤室主任说：“我们对涉及癌症分子途径了解的增加导致在难以治疗疾病中许多肿瘤药物的批准其中少数治疗选择以前存在，” “感谢对刺猬信号通路的更好了解，只是在过去三年，FDA现已两个药物为基底细胞癌的治疗。”在2012年，Erivedge(维莫德吉[vismodegib]是被批准治疗局部晚期和转移基底细胞癌第一个药物。
批准日期：2015年7月24日；公司：Novartis Pharmaceuticals Corporation
ODOMZO®(索尼得吉[sonidegib])胶囊，为口服使用
美国初次批准：2015
作用机制
Sonidegib是一种刺猬信号通路的抑制剂。Sonidegib结合和抑制Smoothened，一种穿膜蛋白涉及刺猬信号传导。
适应证和用途
ODOMZO是一种刺猬信号通路抑制剂适用为手术或放疗后已复发成年患者有局部晚期基底细胞癌(BCC)，或那些不是对手术或放疗被选者的治疗。
剂量和给药方法
推荐剂量：200mg口服每天1次在空腹服用，至少餐前1小时或餐后2小时。
剂型和规格
200 mg胶囊
禁忌证
无。
警告和注意事项
⑴献血：忠告患者用ODOMZO治疗期间不献血或产品和在末次剂量后共至少20个月。
⑵ 肌肉骨骼不良反应：开始治疗前，治疗期间定期地，和当临床上指示时得到血清肌酸激酶 (CK)和肌酐水平。根据肌肉骨骼不良反应的严重程度可能需要暂时中断剂量或ODOMZO的终止。
不良反应
最常见不良反应发生在≥10%患者是肌肉痉挛，脱发，味觉障碍，疲乏，恶心，肌肉骨骼痛，腹泻，体重减轻，食欲减退，肌肉痛，腹痛，头痛，疼痛，呕吐，和瘙痒。
药物相互作用
⑴ CYP3A抑制剂：避免强CYP3A抑制剂。避免长期(长于14天)使用中度CYP3A抑制剂。
⑵CYP3A诱导剂：避免强和中度CYP3A诱导剂。
特殊人群中使用
哺乳：用ODOMZO治疗期间不要哺乳喂养和末次剂量后共至少20个月
General Information
Odomzo (sonidegib) is a hedgehog pathway inhibitor.
Odomzo is specifically indicated for the treatment of adult patients with locally advanced basal cell carcinoma (BCC) that has recurred following surgery or radiation therapy, or those who are not candidates for surgery or radiation therapy.
Odomzo 200mg Capsules,  a new anti cancer drug to treat the most common form of skin cancer, basal cell carcinoma, was just approved by the FDA. Skin cancer is the most common form of cancer.
Odomozo Capsules was cleared treat locally advanced basal cell cancer and is not approved to work against the other two common forms of skin cancer : squamous cell carcinoma and melanoma.
The approval was based on demonstration of a durable objective response rate (ORR) in an international, multi-center, double-blind, randomized, two-arm, non-comparative trial in patients with locally advanced basal cell carcinoma (laBCC) not amenable to local therapy or metastatic basal cell carcinoma (mBCC).
The risk of developing basal cell skin cancers is known to increase from spending lots of time in the sun and exposure to other forms of ultraviolet radiation, like tanning beds.
Odomzo is supplied as a capsule for oral administration. The recommended dose is 200 mg orally once daily taken on an empty stomach, at least 1 hour before or 2 hours after a meal.
http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=77bd079b-7168-454a-ac38-963f8ba34324
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205266s000lbl.pdf