ON NOVEMBER 16, 2018, the U.S. Food and Drug Administration (FDA) expanded the approved use of brentuximab vedotin (Adcetris) injection in combination with chemotherapy for adult patients with certain types of peripheral T-cell lymphoma (PTCL)—adults with previously untreated systemic anaplastic large cell lymphoma or other CD30-expressing PTCL, including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified. This is the first FDA approval for the treatment of newly diagnosed PTCL, and the agency used a new review program to complete the approval more quickly.
Richard Pazdur, MD
“The Real-Time Oncology Review program enables the FDA to access key data prior to the official submission of the application, allowing the review team to begin its review earlier and communicate with the sponsor prior to the application’s actual submission,” said Richard Pazdur, MD, Director of the FDA’s Oncology Center of Excellence and Acting Director of the Office of Hematology and Oncology Products.
THE NEW APPROVAL was based on the phase III ECHELON-2 trial of 452 patients with PTCL who received either brentuximab vedotin plus chemotherapy or standard chemotherapy (CHOP [cyclophosphamide, doxorubicin, vincristine, and prednisone) as first-line treatment. Progression-free survival was significantly longer (hazard ratio = 0.71, P= .01) in the brentuximab vedotin arm (median 48 months vs 21 months with CHOP). Overall survival and overall response rates were also significantly better in the brentuximab vedotin arm.
The most common side effects of brentuximab vedotin plus chemotherapy were peripheral neuropathy, nausea and vomiting, diarrhea, leukopenia, fatigue, mouth sores, constipation, hair loss, fever, and anemia. Health-care providers are advised to monitor patients for infusion reactions, anaphylaxis, neuropathy, fever, gastrointestinal complications, and infections. Patients should also be monitored for tumor-lysis syndrome, serious skin reactions, pulmonary toxicity, and liver damage. ■