FDA Expands Brentuximab Vedotin’s Indication

Brentuximab vedotin has been approved in combination with chemotherapy for the firstline treatment of adult patients with certain peripheral T-cell lymphomas (PTCLs).

The FDA granted this application priority review and breakthrough therapy designation, and this is the first approval for this indication.

The agency issued its decision through an expedited review process for oncology products, the Real-Time Oncology Review (RTOR) program. “[This program] allows 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,” explained 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 two weeks of the completed application’s submission.”

The decision was based on data from a clinical trial of 452 patients with certain PTCLs who received either brentuximab vedotin plus chemotherapy or chemotherapy alone. Median PFS was significantly longer in the brentuximab vedotin group (48 months vs. 21 months [ranges not provided]; p=0.01).

The most common AEs associated with brentuximab vedotin included peripheral neuropathy, nausea and vomiting, diarrhea, leukopenia, fatigue, mouth sores, constipation, hair loss, fever, and anemia. The prescribing information for brentuximab vedotin includes a boxed warning about the risk of a fatal or life-threatening progressive multifocal leukoencephalopathy.

Brentuximab vedotin was previously approved for the treatment of adult patients with previously untreated stage III or IV classical Hodgkin lymphoma.

Source: FDA news release, November 16, 2018.