FDA Approval: Belinostat for the Treatment of Patients with Relapsed or Refractory Peripheral T-cell Lymphoma

被引：276

作者：

Lee, Hyon-Zu ^{[1
]}

Kwitkowski, Virginia E. ^{[1
]}

Del Valle, Pedro L. ^{[1
]}

Ricci, M. Stacey ^{[1
]}

Saber, Haleh ^{[1
]}

Habtemariam, Bahru A. ^{[2
]}

Bullock, Julie ^{[2
]}

Bloomquist, Erik ^{[3
]}

Shen, Yuan Li ^{[3
]}

Chen, Xiao-Hong ^{[4
]}

Brown, Janice ^{[4
]}

Mehrotra, Nitin ^{[2
]}

Dorff, Sarah ^{[2
]}

Charlab, Rosane ^{[2
]}

Kane, Robert C. ^{[1
]}

Kaminskas, Edvardas ^{[1
]}

Justice, Robert ^{[1
]}

Farrell, Ann T. ^{[1
]}

Pazdur, Richard ^{[1
]}

机构：

[1] US FDA, Ctr Drug Evaluat & Res, Off Hematol & Oncol Prod, Off New Drugs, Silver Spring, MD 20993 USA

[2] US FDA, Ctr Drug Evaluat & Res, Off Clin Pharmacol, Silver Spring, MD 20993 USA

[3] US FDA, Ctr Drug Evaluat & Res, Off Biostat, Silver Spring, MD 20993 USA

[4] US FDA, Ctr Drug Evaluat & Res, Off New Drug Qual Assessment, Silver Spring, MD 20993 USA

来源：

CLINICAL CANCER RESEARCH | 2015年 / 21卷 / 12期

关键词：

D O I：

10.1158/1078-0432.CCR-14-3119

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

On July 3, 2014, the FDA granted accelerated approval for belinostat (Beleodaq; Spectrum Pharmaceuticals, Inc.), a histone deacetylase inhibitor, for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). A single-arm, open-label, multicenter, international trial in the indicated patient population was submitted in support of the application. Belinostat was administered intravenously at a dose of 1000 mg/m(2) over 30 minutes once daily on days 1 to 5 of a 21-day cycle. The primary efficacy endpoint was overall response rate (ORR) based on central radiology readings by an independent review committee. The ORR was 25.8% [ 95% confidence interval (CI), 18.3-34.6] in 120 patients that had confirmed diagnoses of PTCL by the Central Pathology Review Group. The complete and partial response rates were 10.8% (95% CI, 5.9-17.8) and 15.0% (95% CI, 9.1-22.7), respectively. The median duration of response, the key secondary efficacy endpoint, was 8.4 months (95% CI, 4.5-29.4). The most common adverse reactions (> 25%) were nausea, fatigue, pyrexia, anemia, and vomiting. Grade 3/4 toxicities (>= 5.0%) included anemia, thrombocytopenia, dyspnea, neutropenia, fatigue, and pneumonia. Belinostat is the third drug to receive accelerated approval for the treatment of relapsed or refractory PTCL. (C)2015 AACR.

引用

页码：2666 / 2670

页数：5

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