The U.S. Food and Drug Administration (FDA) has approved brentuximab vedotin 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.
The approval of brentuximab vedotin comes after the randomized, phase 3, open-label, multicenter ALCANZA trial which studied the use of brentuximab vedotin in patients with mycosis fungoides or pcALCL who had previously received one prior systemic therapy and required systemic treatment. The ALCANZA trial randomly assigned 131 patients 1:1 to receive either brentuximab vedotin or the physician’s choice of either methotrexate or bexarotene.
Factors including improvement in objective response rate lasting 4 months (ORR4), complete response rate, and progression-free survival (PFS) assessed by an independent review facility were used to determine efficacy. The trial showed an improvement (P < .001) in ORR4 in the brentuximab vedotin arm compared with the physician’s choice arm (56% [95% CI: 44%, 68%] vs. 12% [95% CI 4%, 21%], respectively). The brentuximab vedotin arm also experienced superior rates of complete response (P = .007) compared with the physician’s choice arm, 16% (95% CI: 8%, 27%) compared with 2% (95%CI: 0, 8%). The researchers also found an improvement in PFS, the median PFS was 17 months in the brentuximab vedotin arm compared with 4 months in the physician’s choice arm.
More than 20% of patients who received treatment with brentuximab vedotin experienced adverse reactions including anemia, peripheral sensory neuropathy, nausea, diarrhea, fatigue, and neutropenia. Discontinuation of therapy occurred most frequently in relation to 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.
- FDA approves Brentuximab vedotin for the treatment of adult patients with primary cutaneous anaplastic large cell lymphoma [news release]. Silver Spring, MD: US Food and Drug Adiminstration; Updated November 9, 2017. https://www.fda.gov/drugs/informationondrugs/approveddrugs/ucm584543.htm. Accessed November 10, 2017.