U.S. food and drug administration approval: Rituximab in combination with fludarabine and cyclophosphamide for the treatment of patients with chronic lymphocytic leukemia

Oncologist

Volumn 16, Issue 1, 2011, Pages 97-104

  Casak, Sandra J ^a   Lemery, Steven J ^a   Li Shen, Yuan ^a   Rothmann, Mark D ^a   Khandelwal, Aakanksha ^a   Zhao, Hong ^a   Davis, Gina ^a   Jarral, Vaishali ^a   Keegan, Patricia ^a   Pazdur, Richard ^a  

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

Author keywords

Chronic lymphocytic leukemia; Cyclophosphamide; FDA; Fludarabine; Rituximab

Indexed keywords

CYCLOPHOSPHAMIDE; FLUDARABINE; RITUXIMAB;

ADULT; AGE; AGED; ANEMIA; ARTICLE; BRONCHOSPASM; CHRONIC LYMPHATIC LEUKEMIA; CONTROLLED STUDY; DRUG APPROVAL; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG FATALITY; DRUG RESPONSE; DRUG SAFETY; DRUG WITHDRAWAL; DYSPNEA; FEBRILE NEUTROPENIA; FEMALE; FOOD AND DRUG ADMINISTRATION; HEPATITIS B; HUMAN; HYPOTENSION; INFECTION; LEUKOPENIA; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; NEUTROPENIA; OPEN STUDY; PANCYTOPENIA; PHASE 3 CLINICAL TRIAL; PNEUMONIA; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; RANDOMIZED CONTROLLED TRIAL; SEPSIS; SURVIVAL TIME; THROMBOCYTOPENIA; UNSPECIFIED SIDE EFFECT;

AGED; ANTIBODIES, MONOCLONAL, MURINE-DERIVED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CYCLOPHOSPHAMIDE; DRUG APPROVAL; FEMALE; HUMANS; LEUKEMIA, LYMPHOCYTIC, CHRONIC, B-CELL; MALE; MIDDLE AGED; RANDOMIZED CONTROLLED TRIALS AS TOPIC; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION; VIDARABINE;

EID: 79952578096     PISSN: 10837159     EISSN: 1549490X     Source Type: Journal    
DOI: 10.1634/theoncologist.2010-0306     Document Type: Article

References (8)

1. U.S. National Institutes of Health, National Cancer Institute. SEER Stat Fact Sheets: Chronic Lymphocytic Leukemia. Available at http://seer.cancer.gov/statfacts/html/clyl.html, accessed September 1, 2010.
2. Byrd J, Rai K, Peterson B et al. Addition of rituximab to fludarabine may prolong progression-free survival and overall survival in patients with previously untreated chronic lymphocytic leukemia: an updated retrospective comparative analysis of CALGB 9712 and CALGB 9011. Blood 2005;105: 49-53.
3. Rai K, Wasil T, Iqbal U et al. Clinical staging and prognostic markers in chronic lymphocytic leukemia. Hematol Oncol Clin North Am 2004;18: 795-805.
4. Hallek M, Fischer K, Fingerle-Rowson G et al. Addition of rituximab tofludarabine and cyclophosphamide in patients with chronic lymphocytic leukaemia: a randomized, open-label, phase 3 trial. Lancet 2010;376: 1164-1174.
5. Robak T, Dmoszynska A, Solal-Seligny P et al. Rituximab plus fludarabineprolongs progression-free survival compared with fludarabine and cyclophosphamide alone in previously treated chronic lymphocytic leukemia. J Clin Oncol 2010;28:1756-1765.
6. Cheson B, Bennett J, Grever M et al. National Cancer Institute-sponsored Working Group guidelines for chronic lymphocytic leukemia: revised guidelines for diagnosis and treatment. Blood 1996;87:4990-4997.
7. Lemery S, Zhang J, Rothman M et al. U.S. Food and Drug Administration approval: of atumumab for the treatment of patients with chronic lymphocytic leukemia refractory to fludarabine and alemtuzumab. Clin Cancer Res 2010;16(17):4331-4338.
8. Eichhorst B, Busch R, Stilgenbauer S et al. German CLL Study Group(GCLLSG): First-line therapy with fludarabine compared with chlorambucil does not result in a major benefit for elderly patients with advanced chronic lymphocytic leukemia. Blood 2009;114(16):3382-3391.