FDA grants breakthrough therapy designation to Adcetris for advanced classical Hodgkin lymphoma

The FDA granted breakthrough therapy designation to brentuximab vedotin in combination with chemotherapy for frontline treatment of advanced classical Hodgkin lymphoma, according to the drug’s manufacturer.

The agency based the designation on topline data from the randomized phase 3 ECHELON-1 trial, designed to evaluate brentuximab vedotin (Adcetris, Seattle Genetics) — an antibody-drug conjugate directed to CD30 — plus chemotherapy with doxorubicin, vinblastine and dacarbazine, compared with a standard chemotherapy regimen for patients with previously untreated advanced classical Hodgkin lymphoma.

Modified PFS — defined as the time to progression, death or receipt of additional anticancer therapy for patients who did not achieve complete response after completion of frontline therapy — served the primary endpoint.

Secondary endpoints included OS, complete remission and safety.

Researchers reported a significant improvement in modified PFS in the brentuximab vedotin group (HR = 0.77; P = .035), with 2-year modified PFS rates of 82.1% in the brentuximab vedotin group and 77.2% in the chemotherapy alone group.

Interim analysis showed a trend in favor of improved OS with brentuximab vedotin.

The safety profile of brentuximab vedotin plus chemotherapy appeared consistent with that observed with the agent as monotherapy.

“The decision by the FDA to grant this designation recognizes the need for new options that can change the care of people with newly diagnosed advanced Hodgkin lymphoma,” Clay Siegall, PhD, president and CEO of Seattle Genetics, said in a company-issued press release. “The designation supports our goal to have an expeditious review and approval process by the FDA to make Adcetris available to patients in this setting.”

Seattle Genetics plans to submit a supplemental biologics license application for brentuximab vedotin by the end of this year, according to the press release.

Data from the ECHELON-1 trial will be presented at the ASH Annual Meeting and Exposition, which will be held Dec. 9-12 in Atlanta.