Revlimid获准用于特定套细胞淋巴瘤患者

圣路易斯(MD Consult)——2013年6月5日，Celgene公司宣布美国食品药品管理局(FDA)已批准Revlimid(来那度胺)用于经过2种治疗(其中之一为硼替佐米)后复发或病情进展的套细胞淋巴瘤(MCL)患者。Revlimid是一种沙利度胺类似物。该药此前已获准用于多发性骨髓瘤骨髓增生异常综合征患者的治疗。

本项批准令是基于一项2期多中心、单组、开放性研究的结果。该研究在134例已接受了利妥昔单抗、环磷酰胺、1种蒽环类(或米托蒽醌)和硼替佐米单药或联合治疗的MCL患者中对来那度胺进行了评估。研究者要求患者有明确的难治性或复发性疾病。肌酐清除率≥60 ml/min的患者，在每28天中的21天接受来那度胺25 mg/d治疗；肌酐清除率介于30~60 ml/ min的患者，在每28天中的21天接受来那度胺10 mg/d治疗。这项研究的主要终点是由一个独立审查委员会根据改良版国际研讨会淋巴瘤应答标准评定的总应答率，结果总应答率为26%，完全应答率为7%。中位应答持续时间为16.6个月。

Revlimid禁用于孕妇，假如在妊娠期使用该药可能会导致出生缺陷或胚胎-胎儿死亡。只有通过限制性分配计划才能获得这种药物。Revlimid可导致明显的中性粒细胞减少和血小板减少。已有报道称接受Revlimid治疗的患者可发生深静脉血栓和肺栓塞。已有死亡、超敏反应、血管性水肿、Stevens-Johnson综合征和毒性表皮坏死松解等过敏反应的报告。在使用Revlimid的过程中可发生肿瘤溶解综合征，甚至导致患者死亡。在研究性使用Revlimid治疗慢性淋巴细胞性白血病和淋巴瘤时可发生严重肿瘤急性加重。联用Revlimid与地塞米松的患者可发生肝脏衰竭，甚至死亡。在采用Revlimid治疗多发性骨髓瘤患者的对照试验中，观察到第二原发恶性肿瘤的发病率较高。

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ST LOUIS (MD Consult) - On June 5, 2013, Celgene Corporation announced that the US Food and Drug Administration has approved Revlimid (lenalidomide) for the treatment of patients with mantle cell lymphoma (MCL) whose disease has relapsed or progressed after 2 prior therapies, one of which included bortezomib. Revlimid is an analogue of thalidomide. The drug has been previously approved for use in patients with multiple myeloma and myelodysplastic syndrome.

The approval was granted on the basis of results from a phase 2, multicenter, single-arm, open-label study evaluating lenalidomide in 134 patients with MCL who had received prior treatment with rituximab, cyclophosphamide, an anthracycline (or mitoxantrone), and bortezomib alone or in combination. Patients were required to have documented refractory disease or relapsed disease. Patients with creatinine clearance measurements of ≥ 60 mL/min were given lenalidomide at a dose of 25 mg once daily for 21 days every 28 days. Patients with creatinine clearance measurements of ≥ 30 mL/min and < 60 mL/min were given lenalidomide at a dose of 10 mg once daily for 21 days every 28 days. In the study, the primary end point-overall response rate determined after review of radiographic scans by an independent review committee according to a modified version of the International Workshop Lymphoma Response Criteria-was 26% with a complete response rate of 7%. The median duration of response was 16.6 months.

Revlimid is contraindicated in pregnancy, and if used during pregnancy may cause birth defects or embryo-fetal death. It is only available through a restricted distribution program. Revlimid can cause significant neutropenia and thrombocytopenia. Deep venous thrombosis and pulmonary embolism occur in patients who have been treated with Revlimid. Allergic reactions, including fatalities, comprising hypersensitivity, angioedema, Stevens-Johnson syndrome, and toxic epidermal necrolysis have been reported. Tumor lysis syndromes, including fatalities, have been reported during treatment with Revlimid, and serious tumor flare reactions have occurred during investigational use of Revlimid for chronic lymphocytic leukemia and lymphoma. Hepatic failure, including fatal cases, has occurred in patients treated with Revlimid in combination with dexamethasone. Higher incidences of second primary malignancy were observed in controlled trials of patients with multiple myeloma receiving Revlimid.
 

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