11月29日，德国先灵公司（Schering AG）宣布，氟达拉滨口服制剂（fludarabine，Fludara Oral）用于B细胞性慢性淋巴细胞白血病（B-CLL）一线治疗扩大适应症的欧盟二类变更程序（European Union type II variation procedure）已经成功完成。 推荐批准是以一个欧洲II期临床试验为基础，试验证明，新诊断B-CLL患者应用Fludara Oral的应答率及耐受性与已完成静脉注射Fludara治疗的同一疾病患者的反应相当，而且大部分患者取得完全应答，预后良好。 Fludara Oral已在全世界50多个国家获准用于先前使用烷化剂方案治疗失败的B-CLL患者的二线治疗，Fludara的上市产品还有静脉注射剂，除CLL外，Fludara还在加拿大、瑞士及其他国家获准用于分化程度较好(low grade)的非何杰金氏淋巴瘤(NHL)的二线治疗。 FLUDARA FOR INJECTION is indicated for the treatment of patients with B-cell chronic lymphocytic leukemia (CLL) who have not responded to or whose disease had progressed during treatment with at least one standard alkylating-agent containing regimen INDICATIONS AND USAGE FLUDARAFOR INJECTION is indicated for the treatment of adult patients with B-cell chronic lymphocytic leukemia (CLL) who have not responded to or whose disease has progressed during treatment with at least one standard alky- lating-agent containing regimen. The safety and effectiveness of FLUDARAFOR INJECTION in previously untreated or non-refractory patients with CLLhave not been established. CONTRAINDICATIONS FLUDARAFOR INJECTION is contraindicated in those patients who are hypersensitive to this drug or its components. WARNING: FLUDARA FOR INJECTION should be administered under the supervision of a qualified physician experienced in the use of antineoplastic therapy. FLUDARA FOR INJECTION can severely suppress bone marrow function. When used at high doses in dose-ranging studies in patients with acute leukemia, FLUDARA FOR INJECTION was associated with severe neurologic effects, including blindness, coma, and death. This severe central nervous system toxicity occurred in 36% of patients treated with doses approximately four times greater (96 mg/m2/day for 5 to 7 days) than the recommended dose. Similar severe central nervous system toxicity has been rarely (less than or equal to 0.2%) reported in patients treated at doses in the range of the dose recommended for chronic lymphocytic leukemia. Instances of life-threatening and sometimes fatal autoimmune hemolytic anemia have been reported to occur after one or more cycles of treatment with FLUDARA FOR INJECTION. Patients undergoing treatment with FLUDARA FOR INJECTION should be evaluated and closely monitored for hemolysis. In a clinical investigation using FLUDARA FOR INJECTION in combination with pentostatin (deoxycoformycin) for the treatment of refractory chronic lymphocytic leukemia (CLL), there was an unacceptably high incidence of fatal pulmonary toxicity. Therefore, the use of FLUDARA FOR INJECTION in combination with pentostatin is not recommended.