FDA Approval: Belinostat for the Treatment of Patients with Relapsed or Refractory Peripheral T-cell Lymphoma
| Autor: | Xiao Hong Chen, M. Stacey Ricci, Hyon-Zu Lee, Yuan Li Shen, Richard Pazdur, Julie Bullock, Sarah E. Dorff, Rosane Charlab, Haleh Saber, Bahru A. Habtemariam, Robert C. Kane, Robert Justice, Edvardas Kaminskas, Virginia E. Kwitkowski, Erik Bloomquist, Ann T. Farrell, Nitin Mehrotra, Pedro L. Del Valle, Janice Brown |
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| Rok vydání: | 2015 |
| Předmět: |
Cancer Research
medicine.medical_specialty Anemia Nausea Antineoplastic Agents Neutropenia Hydroxamic Acids Gastroenterology chemistry.chemical_compound Refractory Internal medicine medicine Humans Drug Approval Sulfonamides United States Food and Drug Administration business.industry Lymphoma T-Cell Peripheral medicine.disease United States Confidence interval Lymphoma Surgery Histone Deacetylase Inhibitors Oncology chemistry Vomiting medicine.symptom business Belinostat |
| Zdroj: | Clinical Cancer Research. 21:2666-2670 |
| ISSN: | 1557-3265 1078-0432 |
| Popis: | 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/m2 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. Clin Cancer Res; 21(12); 2666–70. ©2015 AACR. |
| Databáze: | OpenAIRE |
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