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FDA批准Daratumumab联合疗法治疗复发性多发性骨髓瘤

2016年11月24日

来源：肿瘤资讯

美国食品和药物管理局（FDA）已批准Daratumumab联合来那度胺（Revlimid，Celgene）和地塞米松或联合硼替佐米和地塞米松治疗二线及以上多发性骨髓瘤。

去年，在这个时候，FDA已经批准Daratumumab单药治疗三线以上多发性骨髓瘤患者。

新的批准是基于III期临床试验的结果。

在开放标签的POLLUX临床试验中，与单用来那度胺和地塞米松相比，达拉木单抗联合来那度胺和地塞米松使患有多发性骨髓瘤患者的疾病进展或死亡风险降低了63％比率[HR]，0.37; 95％置信区间[CI]，0.27-0.52; P <0.0001）。试验结果发表在10月的新英格兰医学杂志。

类似地，在开放标记CASTOR临床试验中，在多发性骨髓瘤患者中，与硼替佐米和地塞米松相比，达拉木单抗联合硼替佐米和地塞米松将疾病进展或死亡的风险降低了61％的治疗（HR，0.39; 95％CI，0.28-0.53; P <0.0001）。这些结果也发表在8月的新英格兰医学杂志，由Medscape医学新闻报道。

来自这两个临床研究的更新结果将在12月初在美国加利福尼亚州圣地亚哥的美国血液学会（ASH）即将召开的年会上作为口头报告。

“虽然在过去十年间在治疗多发性骨髓瘤方面取得了巨大进步，但是患者及其医生仍然需要新的治疗选择，”Meletios Dimopoulos，MD，雅典医学院国家和Kapodistrian大学的Daratumumab研究者指出：“Daratumumab作为单药或与标准的方案结合显示有效，是一个潜在的新的主导药物”Dimopoulos博士说。

总的来说，Daratumumab联合治疗的安全性与已知的Daratumumab单一疗法和来那度胺加地塞米松的安全性一致。对于硼替佐米加地塞米松的达瑞木单抗联合治疗的安全性也是如此。

Daratumumab的推荐剂量为16mg / kg，作为静脉内输注施用。达拉木单抗与来那度胺和地塞米松组合的给药方案以每周使用（第1-8周）开始，随时间减少至每2周（第9-24周），最后每4周（第25周以后）直到疾病进展，。

Daratumumab与硼替佐米和地塞米松组合的给药方案以每周给药（第1-9周），随时间的频率降低至每3周（第10-24周），最后每4周（25周及以后）开始，直到疾病进展。

原文出处

The US Food and Drug Administration (FDA) has approved daratumumab (Darzalex, Janssen) in combination with lenalidomide (Revlimid, Celgene) and dexamethasone or with bortezomib (Velcade, Millennium) and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy.

Last year at this time, the FDA approved the monoclonal antibody as a monotherapy for patients with multiple myeloma who have tried at least three other drug therapies.

The new approval is based on results from phase 3 clinical trials.

In the open-label POLLUX clinical trial, daratumumab in combination with lenalidomide and dexamethasone reduced the risk for disease progression or death by 63%, compared with lenalidomide and dexamethasone alone, in patients with multiple myeloma who received a median of one prior therapy (hazard ratio [HR], 0.37; 95% confidence interval [CI], 0.27 - 0.52; P < .0001). The trial results were published in The New England Journal of Medicine in October, as reported by Medscape Medical News.

Similarly, in the open-label CASTOR clinical trial, daratumumab in combination with bortezomib and dexamethasone reduced the risk for disease progression or death by 61%, compared with bortezomib and dexamethasone alone, in patients with multiple myeloma who received a median of two prior lines of therapy (HR, 0.39; 95% CI, 0.28 - 0.53; P < .0001). These results were also published in The New England Journal of Medicine in August, as reported by Medscape Medical News.

Updated results from both of these clinical studies will be presented as oral presentations at the upcoming annual meeting of the American Society of Hematology (ASH) in San Diego, California, in early December.

"While tremendous progress in the treatment of multiple myeloma has been made in the past decade, patients and their physicians continue to need new treatment options," said Meletios Dimopoulos, MD, a daratumumab investigator at the National and Kapodistrian University of Athens School of Medicine in Greece, in a company press statement.

"With daratumumab, we have a potential new backbone therapy, which has shown pronounced efficacy as either a single agent or in combination with standard of care regimens," said Dr Dimopoulos.

Overall, the safety of the daratumumab combination therapy was consistent with the known safety profiles of daratumumab monotherapy and lenalidomide plus dexamethasone, respectively. The same held true for the safety of the daratumumab combination therapy with bortezomib plus dexamethasone.

The recommended dose of daratumumab is 16 mg/kg body weight administered as an intravenous infusion. The dosing schedule for daratumumab in combination with lenalidomide and dexamethasone begins with weekly administration (weeks 1 - 8), decreasing in frequency over time to every 2 weeks (weeks 9 - 24), and ultimately every 4 weeks (week 25 onward) until disease progression, according to company press materials.

The dosing schedule for daratumumab in combination with bortezomib and dexamethasone begins with weekly administration (weeks 1 - 9), decreases in frequency over time to every 3 weeks (weeks 10 - 24), and ultimately every 4 weeks (weeks 25 and onward) until disease progression, said the company.

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