The FDA has granted regular approval to brentuximab vedotin for the treatment of adults with primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30-expressing mycosis fungoides who have received prior systemic therapy.
Approval was based on a 56% objective response rate for brentuximab vedotin versus 12% for physician’s choice in a phase 3 trial ( ALCANZA ) of 131 patients with mycosis fungoides or pcALCL. All patients had received one prior systemic therapy and were randomized (1:1) to receive either brentuximab vedotin or the physician’s choice of methotrexate or bexarotene, the Food and Drug Administration said in a press statement .
Complete response in the brentuximab vedotin arm was 16% versus 2% in the physician’s choice arm (P = .007). Median progression-free survival was 17 months in the brentuximab vedotin arm versus 4 months in the physician’s choice arm.
The most common adverse reactions for patients in the brentuximab vedotin arm were anemia, peripheral sensory neuropathy, nausea, diarrhea, fatigue, and neutropenia. The most common adverse event leading to discontinuation of brentuximab vedotin was peripheral neuropathy.
The recommended dose of brentuximab vedotin is 1.8 mg/kg up to a maximum of 180 mg/kg as an IV infusion over 30 minutes every 3 weeks until a maximum of 16 cycles, disease progression, or unacceptable toxicity, the FDA wrote.
Brentuximab vedotin is marketed as Adcetris by Seattle Genetics.
ALCANZA results were presented at ASH 2016 and published in the Lancet in Aug. 5, 2017.