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FDA approves Adcetris® (brentuximab vedotin) for treatment of primary cutaneous anaplastic large cell lymphoma
On 9th 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.