First FDA Approval for Newly Diagnosed Types of Peripheral T-Cell Lymphoma

The U.S. Food and Drug Administration (FDA) has approved Adcetris® (brentuximab vedotin) in combination with chemotherapy for the treatment of some peripheral T-cell lymphomas (PTCL). The approval was made through the Real-Time Oncology Review (RTOR) program, a pilot program intended to expedite the approval process by allowing the review team earlier access to clinical trial results. This is the first approval for newly diagnosed PTCL.^1,2

This approval was based on results from the ECHELON-2 trial, a phase 3 clinical trial that looked at 452 patients with certain PTCLs.³ Trial participants received either Adcetris plus chemotherapy or a standard chemotherapy regimen known as CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone). People who received the Adcetris and chemotherapy combination had a median progressional free-survival of 48 months, compared to 21 months for the standard chemotherapy regimen.^1,3 Progression free-survival, or the length of time that the individual is alive without cancer growing, is frequently used as a measure of treatment effectiveness in clinical trials.

Adcetris is a monoclonal antibody, which is a type of targeted therapy (sometimes also considered an immunotherapy). The drug was previously approved for the treatment of some cases of classical Hodgkin lymphoma (cHL), anaplastic large cell lymphoma (ALCL), and mycosis fungoides.¹

What are peripheral T-cell lymphomas?

PTCLs are a rare type of non-Hodgkin lymphoma that impact T-cells. T-cell lymphomas make up about 10-15% of non-Hodgkin lymphoma diagnoses, as B-cell lymphomas are much more common. PTCL is more commonly diagnosed in people over age 60, though younger people and children can develop PTCLs. PTCL also occurs slightly more often in men than women.⁴