FDA approves Adcetris® (brentuximab vedotin) for treatment of primary cutaneous anaplastic large cell lymphoma

On 9^th November 2017, the U.S. Food and Drug Administration (FDA) approved Adcetris^® (brentuximab vedotin) for the treatment of two types of cutaneous T-cell lymphoma, primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30­ expressing mycosis fungoides (MF), in adults who have received prior systemic therapy. 

This approval was based on data from the ALCANZA phase III, randomized, open-label, multicenter clinical trial previously reported by Lymphoma Hub on 12th July 2017. The results showed brentuximab vedotin to significantly improve patient objective response rate lasting 4 months or more and complete responses, as well as improving PFS. In a video interview with Lymphoma Hub, Professor Miles Prince, an author of the published study, said the results "showed a substantial difference between the comparator arms and brentuximab vendotin" with "over a 50% difference".

The full indication and usage from the prescribing information is as follows:

Adcetris® is a CD30-directed antibody-drug conjugate for adults with primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30­ expressing mycosis fungoides (MF) who have received prior systemic therapy.