BENDEKA is indicated for the treatment of patients with chronic lymphocytic leukemia (CLL). Efficacy relative to first-line therapies other than chlorambucil has not been established.
Bendamustine HCl demonstrated robust efficacy results in CLL1
Bendamustine tripled median PFS* compared with chlorambucil (18 months [95% CI: 11.7, 23.5] vs 6 months [95% CI: 5.6, 8.6])1
PROGRESSION-FREE SURVIVAL (PFS)1


CI=confidence interval; HR=hazard ratio;
*PFS was defined as time from randomization to progression or death from any cause. Graph based on Kaplan-Meier estimates.
Pivotal study design1
Bendamustine HCl was compared with chlorambucil in a randomized, open-label, phase 3 trial in treatment-naïve patients with Binet Stage B or C (Rai Stages I-IV) CLL who required treatment (N=301).
Patients aged 45-77 years were scheduled to receive either bendamustine HCl 100 mg/m2 intravenously using the 30-minute formulation on Days 1 and 2 (n=153) or chlorambucil 0.8 mg/kg orally on Days 1 and 15 (n=148) of a 28-day treatment cycle, up to 6 cycles. Efficacy endpoints were ORR and PFS. *ORR=overall response rate.
CI=confidence interval; HR=hazard ratio; ORR=overall response rate.
*PFS was defined as time from randomization to progression or death from any cause. Graph based on Kaplan-Meier estimates.
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More than 2x ORR1
Bendamustine delivered ORR† that was more than double that of chlorambucil (59% [95% CI: 51.0, 66.6] vs 26% [95% CI: 18.6, 32.7], respectively; P<0.0001)
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Complete responses1
8% of patients (n=13) treated with bendamustine achieved a complete response compared with <1% of patients (n=1) treated with chlorambucil‡
National Comprehensive Cancer Network® (NCCN®)
NCCN Guidelines® recommend (Category 2A) the use of bendamustine in the treatment of CLL2
†ORR was defined as complete response + nodular partial response + partial response.
‡Complete response was defined as peripheral lymphocyte count ≤4 x 109/L, neutrophils ≥1.5 x 109/L, platelets <100 x 109/L, hemoglobin >110 g/L, without transfusions, absence of palpable hepatosplenomegaly, lymph nodes ≤1.5 cm, <30% lymphocytes without nodularity in at least a normocellular bone marrow and absence of "B" symptoms. The clinical and laboratory criteria were required to be maintained for a period of at least 56 days.
Reference: 1. BENDEKA® (bendamustine hydrochloride) injection [Current Prescribing Information]. North Wales, PA: Teva Pharmaceuticals USA, Inc. 2. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma V4.2019. © National Comprehensive Cancer Network, Inc. 2016. All rights reserved. Accessed March 19, 2019. To view the most recent and complete version of the guideline, go online to NCCN.org. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, NCCN GUIDELINES®, and all other NCCN Content are trademarks owned by the National Comprehensive Cancer Network, Inc.