FDA Expands Approved Use of Brentuximab Vedotin in Some Types of PTCL
Today, 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. The agency used a new review program to complete the approval more quickly.
“The Real-Time Oncology Review (RTOR) program enables the FDA to access key data prior to the official submission of the application, allowing the review team to begin their 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. “When the sponsor submits the completed application, the review team will already be familiar with the data and be able to conduct a more efficient, timely and thorough review. RTOR allowed the FDA to approve this indication within 2 weeks of the completed application’s submission.”
ECHELON-2
The new approval was based on the phase III ECHELON-2 clinical trial of 452 patients with certain PTCLs who received either brentuximab vedotin plus chemotherapy or a 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.
The prescribing information for brentuximab vedotin includes a boxed warning to advise health-care professionals and patients about the risk of a potentially fatal progressive multifocal leukoencephalopathy in patients receiving brentuximab vedotin.
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
