FDA Approves Brentuximab Vedotin for Primary Cutaneous Anaplastic Large Cell Lymphoma

Today, the U.S. Food and Drug Administration (FDA) granted regular approval to brentuximab vedotin (Adcetris) for the treatment of adult patients with primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30-expressing mycosis fungoides who have received prior systemic therapy.


Approval was based on the phase III, randomized, open-label, multicenter ALCANZA trial of brentuximab vedotin in patients with mycosis fungoides 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.

Efficacy was established based on improvement in objective response rate lasting 4 months, complete response rate, and progression-free survival assessed by an independent review facility.

ALCANZA demonstrated an improvement (P < .001) in objective response rate lasting 4 months in the brentuximab vedotin arm vs the physician’s choice arm, 56% (95% confidence interval [CI] = 44%–68%) vs 12% (95% CI = 4%–21%), respectively. Complete response rate was also superior (P = .007) in the brentuximab vedotin arm vs the physician’s choice arm, 16% (95% CI = 8%–27%) vs 2% (95% CI = 0%–8%). ALCANZA also demonstrated improvement in progression-free survival with an estimated hazard ratio of 0.27 (95% CI = 0.17–0.43, P < .001). The median progression-free survival was 17 months in the brentuximab vedotin arm vs 4 months in the physician’s choice arm.

The most common adverse reactions occurring in > 20% of patients receiving brentuximab vedotin were anemia, peripheral sensory neuropathy, nausea, diarrhea, fatigue, and neutropenia. The most common adverse event leading to discontinuation was peripheral neuropathy.

The recommended dose of brentuximab vedotin is 1.8 mg/kg up to a maximum of 180 mg as an intravenous infusion over 30 minutes every 3 weeks until a maximum of 16 cycles, disease progression, or unacceptable toxicity.

Full prescribing information is available at https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125388_S056S078lbl.pdf.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.




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