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FDA Expands Approval of Injection to Include Peripheral T-Cell Lymphomas
The FDA has approved brentuximab vedotin (Adcetris; Seattle Genetics) for use in combination with chemotherapy in the treatment of adults with untreated systemic anaplastic large cell lymphoma (ALCL) and other CD30-expressing peripheral T-cell lymphomas. This is the first drug approval for newly diagnosed peripheral T-cell lymphomas.
Brentuximab vedotin was previously approved by the FDA for the treatment of adults with untreated stage III or stage IV classical Hodgkin lymphoma (cHL), relapsed cHL, cHL after stem cell transplant in patients at a high risk for disease relapse or progression, and systemic ALCL, primary cutaneous ALCL, or CD30-expressing mycosis fungoides that don’t respond to other treatments.
The expanded approval of brentuximab vedotin was based on results from a clinical trial of 425 patients with peripheral T-cell lymphomas who received brentuximab vedotin plus chemotherapy or a CHOP chemotherapy regimen alone as first-line therapy.
The median progression-free survival was significantly longer in the brentuximab vedotin arm than in the CHOP arm (48 months vs 21 months, respectively). Overall survival and response rates were also significantly better with brentuximab vedotin than with CHOP.
The most common side effects observed with brentuximab vedotin plus chemotherapy include nerve damage, nausea and vomiting, diarrhea, low white or red blood cell counts, fatigue, mouth sores, constipation, hair loss, and fever.—Janelle Bradley
