FDA Grants Breakthrough-Therapy Designation to Brentuximab Vedotin for Frontline Treatment of HL

The FDA granted breakthrough-therapy designation to brentuximab vedotin (BV) for frontline treatment of classical Hodgkin lymphoma (cHL).

The decision was based on results from the global, multicenter, phase III ECHELON-1 trial of 1,334 patients with histologically confirmed stage III or IV cHL who had not received systemic chemotherapy or radiotherapy. In the study, BV plus AVD (adriamycin, vinblastine, dacarbazine) resulted in a two-year modified progression-free survival rate (defined as time to progression, death, or receipt of additional anti-cancer therapy for patients who did not achieve complete response) of 82.1 percent, compared with 77.2 percent among patients who received ABVD (adriamycin, bleomycin, vinblastine, dacarbazine). BV plus AVD also reduced the risk of disease progression or death by 23 percent (hazard ratio = 0.77; p=0.035).

A previous phase I study observed the following grade ≥3 AEs (>10% of patients) in patients receiving BV plus ABVD or AVD: neutropenia (80% vs. 65%), anemia (20% vs. 12%), febrile neutropenia (20% vs. 8%), and pulmonary toxicity (24% vs. 0%).

Source: Seattle Genetics press release, October 2, 2017.

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