The U.S. Food and Drug Administration has approved brentuximab vedotin (Adcetris) for the treatment of adults with primary cutaneous anaplastic large cell lymphoma- it is the most common subtypes of cutaneous T-cell lymphoma with classical Hodgkin lymphoma as post autologous hematopoietic stem cell transplantation consolidation at high risk of relapse or progression, Seattle Genetics has announced.
The approval is based a phase III, randomized, open-label, multicenter clinical trial (ALCANZA) that was designed to compare up to 16 cycles (approximately 1 year) of brentuximab vedotin in patients with mycosis fungoides (MF) or pcALCL who had previously received one prior systemic therapy and required systemic treatment. This therapy administered every 3 weeks following autologous hematopoietic stem cell transplantation to placebo. It is marketed by US biotech firm Seattle Genetics (Nasdaq: SGEN) in the USA and Canada, Adcetris is now cleared for the treatment of adult patients with primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30.
Based on improvement, efficacy was established in major secondary endpoints such as objective response rate lasting 4 months ORR (67.2% vs. 20.3%), complete response rate (P=0.0066), and progression-free survival (P<0.001). ALCANZA demonstrated improvement in progression-free survival (PFS). Median progression-free survival (PFS) was 17 months in the brentuximab vedotin arm versus 4 months in the physician’s choice arm.
Anemia, peripheral sensory neuropathy, nausea, diarrhea, fatigue, and neutropenia were the most commonly reported adverse reactions for patients receiving brentuximab vedotin occurring in ≥20% of patients.
The dosage 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.
ADCETRIS received marketing authorization by regulatory authorities in 68 countries for relapsed or refractory Hodgkin lymphoma and sALCL. See important safety information below.
“Both patient and representative of the cutaneous lymphoma community, FDA granted approval of Adcetris as a new treatment option for the most common subtypes of cutaneous T-cell lymphoma among patients who require systemic therapy and looking forward to sharing this important milestone with patients and physicians,” Susan Thornton, CEO of the Cutaneous Lymphoma Foundation, said in the release.
The FDA granted brentuximab vedotin for the treatment of cutaneous T-cell lymphoma in August it is marketed as Adcetris by Seattle Genetics.