简介：

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。

Pixuvri: new option in the treatment of non-Hodgkin's B-cell lymphoma
Pixuvri (pixantrone) is indicated as monotherapy in the treatment of multiply relapsed or refractory aggressive non-Hodgkin's B-cell lymphoma.
The licensed adult dose of pixantrone is 50mg/m2 by intravenous infusion on days 1, 8 and 15 of each 28-day cycle for up to six cycles

PHARMACOLOGY
Pixantrone is a cytotoxic aza-anthracenedione. It has shown minimal cardiotoxicity in animal models compared with doxorubicin or mitoxantrone.1

CLINICAL STUDIES
Salvage treatment
The safety and efficacy of pixantrone were eva luated in a phase III open-label trial involving 140 patients with aggressive non-Hodgkin's lymphoma who had relapsed after two or more previous chemotherapy regimens including at least one standard anthracycline-containing regimen with a response that lasted at least 24 weeks.2

Patients were randomised to receive pixantrone (85mg/m2 by intravenous infusion over one hour on days 1, 8 and 15 of a 28-day cycle for up to six cycles, n=70) or their investigator’s choice of comparator agent at pre-specified standard doses and schedules (n=70).2 Comparator agents included vinorelbine, oxaliplatin, ifosfamide, etoposide, mitoxantrone, gemcitabine and rituximab.2

Complete responses
In the ITT population, significantly more patients achieved a complete or unconfirmed complete response at the end of treatment with pixantrone than with a comparator agent (14 [20%, 95% CI 11.4-31.3] vs 4 [5.7%, 95% CI 1.6-14.0], p=0.021).2

In addition, the overall number of responses (complete, unconfirmed complete or partial) was significantly greater in the pixantrone group than in the comparator group (26 [37.1%, 95% CI 25.9-49.5] vs 10 [14.3%, 95% CI 7.1-24.7]; p=0.003).2 

Median progression-free survival was significantly longer in the pixantrone group than in the comparator group (5.3 months vs 2.6 months, p=0.005).2

Median overall survival was also greater in the pixantrone group than in the comparator group although the difference was not significant.2

Safety profile
The most commonly observed grade 3 or 4 adverse events in the pixantrone group were neutropenia, leucopenia and thrombocytopenia, all of which occurred at a greater rate than in the comparator group.2

The incidence of cardiac adverse events was also higher in the pixantrone group than in the comparator group (35.3% vs 20.9%, respectively); however, these were predominantly asymptomatic grade 1 or 2 declines in left ventricular ejection fraction and did not increase with increasing pixantrone exposure.2
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