Posted by Michael Wonder on 10 Nov 2017
Seattle Genetics announces FDA approval of Adcetris (brentuximab vedotin) for primary cutaneous anaplastic large cell lymphoma and CD30 expressing mycosis fungoides
9 November 2017 - FDA approval based on clinical trial results from the Phase 3 ALCANZA and Phase 2 investigator-sponsored studies in cutaneous T-cell lymphoma.
Seattle Genetics announced today that the U.S. FDA has approved Adcetris (brentuximab vedotin) for the treatment of adult patients with primary cutaneous anaplastic large cell lymphoma (pcALCL) and CD30-expressing mycosis fungoides (MF) who have received prior systemic therapy. Primary cutaneous ALCL and MF are the most common subtypes of cutaneous T-cell lymphoma (CTCL).
The phase 3 ALCANZA study was designed to compare ADCETRIS monotherapy administered every three weeks versus physician’s choice of representative standard of care options, methotrexate or bexarotene. The trial met its primary endpoint with the Adcetris treatment arm demonstrating a highly statistically significant improvement in the rate of objective response lasting at least four months (ORR4) versus the control arm as assessed by an independent review facility. ORR4 was 56.3% (95% CI: 44.1, 68.4) in the Adcetris arm compared to 12.5 percent (95% CI: 4.4, 20.6) in the control arm (p-value <0.001). The most common adverse reactions (≥ 20%) were: anaemia, peripheral sensory neuropathy, nausea, diarrhoea, fatigue and neutropenia.
