TREANDA® is indicated for the treatment of patients with CLL. Efficacy relative to first-line therapies other than chlorambucil has not been established.

TREANDA is synthesized to combine an alkylating group and a benzimidazole component. Bifunctional covalent linkage can lead to cell death via several pathways. TREANDA causes DNA damage, and TREANDA is active against quiescent and dividing cells.

The exact mechanism of action of TREANDA remains unknown.

In the phase 3 pivotal trial, TREANDA demonstrated significant progression-free survival (PFS) vs chlorambucil with a manageable side-effect profile

The efficacy and safety of TREANDA were assessed compared with chlorambucil in a multicenter trial in treatment-naïve patients with Binet Stage B or C (Rai stages I-IV) CLL who required treatment (N=301: TREANDA, n=153; chlorambucil, n=148). Patients were randomized to receive either single-agent TREANDA 100 mg/m2 IV on Days 1 and 2 or single-agent chlorambucil 0.8 mg/kg PO on Days 1 and 15, for up to six 28-day cycles.

Primary efficacy end points were progression-free survival (PFS) and overall response rate (ORR). A stringent prespecified algorithm was applied to assess PFS and ORR based on National Cancer Institute Working Group criteria.

TREANDA vs chlorambucil

  • Statistically significant overall response rate (ORR) (59% vs 26%; P<.0001)
  • More than 8 times greater complete response (CR) (8% vs <1%)
  • Greater nodular partial response (nPR) (3% vs 0%)
  • Nearly 2 times greater partial response (PR) (48% vs 25%)

Side-effect profile

  • The most common hematologic adverse events >15% with TREANDA were neutropenia (28%), thrombocytopenia (23%), anemia (19%), and leukopenia (18%)
  • The most common non-hematologic adverse events >15% with TREANDA were pyrexia (24%), nausea (20%), and vomiting (16%)

Please see the full Prescribing Information.