NICE has approved brentuximab vedotin for the second-line treatment of CD30‑positive cutaneous T‑cell lymphoma (CTCL) in adults with mycosis fungoides stage ≥IIB, primary cutaneous anaplastic large cell lymphoma or Sézary syndrome.
The main evidence for brentuximab came from the multicentre, open-label, randomised controlled ALCANZA trial, which included 128 adults (median age 60 years) with CTCL (mycosis fungoides or primary cutaneous anaplastic large cell lymphoma) who had received one previous systemic therapy and had an Eastern Cooperative Oncology Group (ECOG) performance status of 2 and under. Ninety-five patients had advanced CTCL.
The trial compared brentuximab with physician's choice of treatment (either methotrexate or bexarotene). Objective response rate (ORR) lasting ≥4 months was found to be 59.2% with brentuximab vs 8.7% with methotrexate or bexarotene (P
ALCANZA did not assess the comparative effectiveness of brentuximab and interferon alfa. However, NICE accepted that the improved PFS and longer clinical responses seen with brentuximab compared to methotrexate or bexarotene would also be the case when compared with interferon alpha.
The adverse effects reported in the ALCANZA study were broadly comparable between the brentuximab and comparator groups.