2010年10月19日，Cell Therapeutics公司宣布，其抗癌药物Pixuvri(R)（pixantrone dimaleate) 得到欧洲药品管理局（European Medicines Agency，EMA）小儿委员会（PDCO)就其将用于治疗6个月-18岁儿童的淋巴系统恶性肿瘤（lymphoid malignancies）和实体瘤（solid tumors）正面评价。这正面观点将为其在欧盟（EU）就治疗复发性或难治性非霍奇金淋巴瘤(NHL)的上市许可申请(Marketing Authorization Application，MAA)铺平了道路。
pixantrone (Pixuvri®)
pixantrone (Pixuvri®) 29 mg powder for concentrate for solution for infusion
Company: Cell Therapeutics Inc
BNF category: Malignant disease and immunosupression
Status: Superseded
Advice : Not available
ratification: 25/10/2012
Pixuvri 29 m
Les laboratoires servier industrie offers a wide range of products which includes pixuvri 29 mg. Form: powder for concentrate for solution for infusion. Dark blue lyophilised powder. Therapeutic indications: it is indicated as monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive non-hodgkin b-cell lymphomas (nhl). The benefit of pixantrone treatment has not been established in patients when used as fifth line or greater chemotherapy in patients who are refractory to last therapy.
Packaging: 29 mg powder for concentrate for solution for infusion.
About Pixuvri (pixantrone)
Pixuvri is a novel aza-anthracenedione that has distinct structural and physio-chemical properties that make its anti-tumor activity unique in this class of agents. Similar to anthracyclines, Pixuvri inhibits Topo-isomerase II but unlike anthracyclines — rather than intercalation with DNA – Pixuvri alkylates DNA — forming stable DNA adducts with particular specificity for CpG-rich, hyper-methylated sites. These structural differences resulted in significantly enhanced anti-lymphoma activity compared to doxorubicin in preclinical models. In addition, the structural motifs on anthracycline-like agents that are responsible for the generation of oxygen free radicals and the formation of toxic drug-metal complexes have also been modified in Pixuvri in an effort to prevent the binding of iron and perpetuation of superoxide production — both of which are the putative mechanism for anthracycline induced acute cardiotoxicity. These novel pharmacologic differences may allow re-introduction of anthracycline-like potency in the treatment of relapsed/refractory diffuse large cell lymphoma without unacceptable rates of cardiotoxicity.
http://www.medicines.org.uk/emc/medicine/29829
pixantrone（Pixuvri）扩大适应症用于淋巴瘤治疗
pixantrone（Pixuvri）将为医师增加一个重要的治疗选择，也将为患者产生有意义的影响。
Pixuri被批准用于治疗多次复发或难治性侵袭性非霍奇金B细胞淋巴瘤患者的治疗。pixantrone（Pixuvri）是蒽环类化疗药物家族中的一员。
Pixuri目前用于复发性、侵袭性非何杰金淋巴瘤（NHL）的治疗。I/II期临床研究显示，pixantrone（Pixuvri）单一用药的疾病完全缓解率达到20%，当pixantrone（Pixuvri）替换了标准治疗药物CHOP（环磷酰胺+多柔比星+长春新碱+泼尼松）中的多柔比星时，疾病的完全缓解率达到59%.III期临床也获得了肯定结果。
对于本品的潜在治疗领域包括各种何杰金恶性瘤、实体瘤和免疫疾病，研究者期望pixantrone（Pixuvri）能提高蒽环类药物的安全性和有效性。标准治疗药物蒽环霉素已显示出治疗癌症的强有效性，但蒽环霉素总是与累积心脏损伤相关，这大大缩减了蒽环霉素的使用范围。pixantrone（Pixuvri）较蒽环霉素更易于服药。而且，迄今为止还未发现pixantrone（Pixuvri）有严重的心脏不良反应。pixantrone（Pixuvri）将朝着减少心脏毒性、增加治疗有效性和方便患者用药的方向发展。