FDA approves Adcetris for adult patients with primary cutaneous anaplastic large cell lymphoma

The US Food and Drug Administration yesterday granted regular approval for a fourth indication for Adcetris (brentuximab vedotin).

Marketed by US biotech firm Seattle Genetics (Nasdaq: SGEN) in the USA and Canada, Adcetris is now cleared for the treatment of adult patients with primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30-expressing mycosis fungoides (MF) who have received prior systemic therapy.

Approval was based on a Phase III, randomized, open-label, multicenter clinical trial (ALCANZA) of brentuximab vedotin in patients with MF or pcALCL who had previously received one prior systemic therapy and required systemic treatment. The trial randomized 131 patients (1:1) to receive either brentuximab vedotin or the physician’s choice of methotrexate or bexarotene.