FDA approval: Belinostat for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma

Clinical Cancer Research

Volumn 21, Issue 12, 2015, Pages 2666-2670

  Lee, Hyon Zu ^a   Kwitkowski, Virginia E ^a   Del Valle, Pedro L ^a   Ricci, M Stacey ^a   Saber, Haleh ^a   Habtemariam, Bahru A ^a   Bullock, Julie ^a   Bloomquist, Erik ^a   Shen, Yuan Li ^a   Chen, Xiao Hong ^a   Brown, Janice ^a   Mehrotra, Nitin ^a   Dorff, Sarah ^a   Charlab, Rosane ^a   Kane, Robert C ^a   Kaminskas, Edvardas ^a   Justice, Robert ^a   Farrell, Ann T ^a   Pazdur, Richard ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BELINOSTAT; HEMOGLOBIN; LACTATE DEHYDROGENASE; ANTINEOPLASTIC AGENT; HISTONE DEACETYLASE INHIBITOR; HYDROXAMIC ACID; SULFONAMIDE;

ABDOMINAL PAIN; ADULT; AGED; ANEMIA; ARTICLE; BONE MARROW SUPPRESSION; CHILL; CONSTIPATION; CONTROLLED STUDY; COUGHING; DECREASED APPETITE; DIARRHEA; DIZZINESS; DRUG APPROVAL; DRUG DISPOSITION; DRUG DOSE ESCALATION; DRUG EFFICACY; DRUG EXCRETION; DRUG INHIBITION; DRUG SAFETY; DYSPNEA; FATIGUE; FEMALE; FEVER; FOOD AND DRUG ADMINISTRATION; HEADACHE; HEMOGLOBIN BLOOD LEVEL; HUMAN; HYPOKALEMIA; HYPOTENSION; IN VITRO STUDY; INCIDENCE; INJECTION SITE PAIN; LACTATE DEHYDROGENASE BLOOD LEVEL; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; NAUSEA; NEUTROPENIA; OPEN STUDY; OVERALL SURVIVAL; PERIPHERAL EDEMA; PERIPHERAL T CELL LYMPHOMA; PHASE 1 CLINICAL TRIAL; PHASE 2 CLINICAL TRIAL; PHLEBITIS; PNEUMONIA; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; PRURITUS; QT PROLONGATION; RASH; THROMBOCYTE COUNT; THROMBOCYTOPENIA; TREATMENT DURATION; TREATMENT RESPONSE; VOMITING; LYMPHOMA, T-CELL, PERIPHERAL; PATHOLOGY; UNITED STATES;

ANTINEOPLASTIC AGENTS; DRUG APPROVAL; HISTONE DEACETYLASE INHIBITORS; HUMANS; HYDROXAMIC ACIDS; LYMPHOMA, T-CELL, PERIPHERAL; SULFONAMIDES; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84939522027     PISSN: 10780432     EISSN: 15573265     Source Type: Journal    
DOI: 10.1158/1078-0432.CCR-14-3119     Document Type: Article

References (9)

1. Mak V, Hamm J, Chhanabhai M, Shenkier T, Klasa R, Sehn L, et al. Survival of patients with peripheral T-cell lymphoma after first relapse or progression: spectrum of disease and rare long-term survivors. J Clin Oncol 2013;31: 1970-6.
2. O'Leary HM, Savage KJ. Novel therapies in peripheral T-cell lymphomas. Curr Oncol Rep 2008;10:404-11.
3. Foss F. Evolving therapy of peripheral T-cell lymphoma: 2010 and beyond. Ther Adv Hematol 2011;2:161-73.
4. Chen AI, Advani RH. Beyond the guidelines in the treatment of peripheral T-cell lymphoma: new drug development. J Natl Compr Canc Netw 2008; 6:428-35.
5. NCCN clinical practice guidelines in oncology. (NCCN Guidelines). Fort Washington (PA): National Comprehensive Cancer Network (US); 2014 [cited 2015 Feb 23]. NCCN guidelines for treatment of cancer by site; non-Hodgkin's lymphomas. Version 5.2014. Available from: www.NCCN.org.
6. Foss FM, Zinzani PL, Vose JM, Gascoyne RD, Rosen ST, Tobinai K. Peripheral T-cell lymphoma. Blood 2011;117:6756-67.
7. Guidance for industry: expedited programs for serious conditions-drugs and biologics [PDF onthe Internet]. Silver Spring(MD): U.S. Food and Drug Administration; 2014 [cited 2015 Feb 23]. Available from: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM358301.pdf.
8. Sridhara R, Johnson JR, Justice R, Keegan P, Chakravarty A, Pazdur R. Review of oncology and hematology drug product approvals at the US Food and Drug Administration between July 2005 and December 2007. J Natl Cancer Inst 2010;102:230-43.
9. Guidance for industry: clinical trial endpoints for the approval of cancer drugs and biologics. [PDF on the Internet]. Silver Spring (MD): U.S. Food and Drug Administration; 2007 [cited 2015 Feb 23]. Available from: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM071590.pdf.