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

Abstract

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.

• Authors: Hyon-Zu Lee, Virginia E Kwitkowski, Pedro L Del Valle, M Stacey Ricci, Haleh Saber, Bahru A Habtemariam, Julie Bullock, Erik Bloomquist, Yuan Li Shen, Xiao-Hong Chen, Janice Brown, Nitin Mehrotra, Sarah Dorff, Rosane Charlab, Robert C Kane, Edvardas Kaminskas, Robert Justice, Ann T Farrell, Richard Pazdur
• Journal: Clinical cancer research : an official journal of the American Association for Cancer Research (Clin Cancer Res) Vol. 21 Issue 12 Pg. 2666-70 (Jun 15 2015) ISSN: 1557-3265 [Electronic] United States
• PMID: 25802282 (Publication Type: Letter)
• Copyright: ©2015 American Association for Cancer Research.

Chemical References

• Antineoplastic Agents
• Histone Deacetylase Inhibitors
• Hydroxamic Acids
• Sulfonamides
• belinostat

Topics

• Antineoplastic Agents (therapeutic use)
• Drug Approval
• Histone Deacetylase Inhibitors (therapeutic use)
• Humans
• Hydroxamic Acids (therapeutic use)
• Lymphoma, T-Cell, Peripheral (drug therapy, pathology)
• Sulfonamides (therapeutic use)
• United States
• United States Food and Drug Administration