ELITEK® (rasburicase) was studied in adults at high and intermediate (potential) risk of TLS1

92%

of adult patients were at high risk for tumor lysis syndrome (TLS) at baseline1

82%

of adult patients had normal uric acid levels (≤7.5 mg/dL) at baseline1

Adult patients meeting at least 1 of the following criteria were enrolled in the pivotal trial1:

HIGH RISK1-3

Aggressive lymphoma/leukemia (defined by REAL)

  • DLBCL
  • Anaplastic large cell lymphoma
  • Peripheral T-cell lymphomas
  • Burkitt lymphoma
  • Lymphoblastic lymphoma
  • CLL

AML


Elevated plasma uric acid levels (>7.5 mg/dL) at baseline


High-grade MDS with >10% bone marrow blast involvement


CML in blast crisis

INTERMEDIATE (POTENTIAL) RISK1

Aggressive lymphoma/leukemia, not limited to the REAL definition, with LDH ≥2x the upper limit of normal



Any stage III to IV aggressive lymphoma or leukemia


Stage I or II aggressive disease with bulky lymph node/tumor (>5 cm) involvement

Michael R.Bishop, MD

EXPERT REVIEW VIDEO

Watch Dr. Michael R. Bishop explain why patients with uric acid levels of ≥7.5 mg/dL would be considered at high risk for developing TLS

ELITEK Efficacy and Safety Flashcard

Use this efficacy and safety flashcard to see the head-to-head pivotal trial data between ELITEK and allopurinol

Antihyperuricemic therapy in all 3 arms was initiated prior to anticancer therapy1,4

  • Phase 3: randomized, multicenter, open-label study in adult patients (N=275) with leukemia, lymphoma, and solid tumor malignancies at risk for hyperuricemia and TLS
  • Primary endpoint: response rate defined as the proportion of adult patients with plasma uric acid levels maintained at ≤7.5 mg/dL between 3 and 7 days after initiation of antihyperuricemic treatment
ADULT PIVOTAL TRIAL DESIGN1,4
Randomized, multicenter, open-label study comparing ELITEK vs allopurinol (N=275) administered 4 to 24 hours prior to anticancer therapy 
ADULT PIVOTAL TRIAL DESIGN1,4
Randomized, multicenter, open-label study comparing ELITEK vs allopurinol (N=275) administered 4 to 24 hours prior to anticancer therapy 
See how these adults responded to treatment with ELITEK

EXPLORE ADULT EFFICACY

AML=acute myeloid leukemia; CLL=chronic lymphocytic leukemia; CML=chronic myeloid leukemia; DLBCL=diffuse large B-cell lymphoma; LDH=lactate dehydrogenase; MDS=myelodysplastic syndrome; REAL=Revised European American Classification of Lymphoid Neoplasms.

References: 1. Cortes J, Moore JO, Maziarz RT, et al. Control of plasma uric acid in adults at risk for tumor lysis syndrome: efficacy and safety of rasburicase alone and rasburicase followed by allopurinol compared with allopurinol alone—results of a multicenter phase III study. J Clin Oncol. 2010;28(27):4207-4213. 2. Jakić-Razumović J, Aurer I. The World Health Organization classification of lymphomas. Croat Med J. 2002;43(5):527-534. 3. Nicolaides C, Dimou S, Pavlidis N. Prognostic factors in aggressive non-Hodgkin’s lymphomas. Oncologist. 1998;3(3):189-197. 4. ELITEK [prescribing information]. Bridgewater, NJ: sanofi-aventis U.S. LLC.