FDA grants priority review to Adcetris for initial treatment of advanced classical Hodgkin lymphoma

The FDA granted priority review to a supplemental biologics license application that seeks approval of brentuximab vedotin in combination with chemotherapy for initial treatment of advanced classical Hodgkin lymphoma.

Brentuximab vedotin (Adcetris, Seattle Genetics) is an antibody-drug conjugate directed to CD30, a defining marker of classical Hodgkin lymphoma.

The FDA based the designation on results of the open-label, randomized phase 3 ECHELON-1 trial, presented in December at the ASH Annual Meeting and Exposition and published simultaneously in The New England Journal of Medicine.

The analysis included 1,334 patients (median age, 36 years; 58% men) with previously untreated stage III or stage IV classical Hodgkin lymphoma.

Researchers randomly assigned patients to brentuximab vedotin plus AVD chemotherapy — which consists of adriamycin, vinblastine and dacarbazine — or standard ABVD chemotherapy, which consists of doxorubicin, bleomycin, vinblastine and dacarbazine.

Researchers reported improved modified PFS

Modified PFS — defined as time to progression, death or evidence of incomplete response followed by subsequent anticancer therapy — as determined by independent review facility assessment served as the primary endpoint.

As HemOnc Today previously reported, patients assigned the brentuximab vedotin regimen achieved significantly longer modified PFS (P = .035), corresponding to a 23% reduction in risk for progression, death or need for additional anticancer therapy.

Two-year modified PFS rates were 82.1% in the brentuximab vedotin-AVD group and 77.2% in the ABVD group.

All secondary endpoints, including an interim analysis of OS, trended in favor of the brentuximab vedotin regimen.

The safety profile of the brentuximab vedotin combination appeared consistent with that observed with prior use of the regimen’s components as single agents.

The FDA previously granted breakthrough therapy designation to the regimen based on the ECHELON-1 results.

The FDA is scheduled to make a decision on the regimen’s approval status by May 1.

“The FDA’s filing of our supplemental biologics license application with priority review represents a significant milestone in our goal to redefine the frontline treatment of advanced Hodgkin lymphoma,” Clay Siegall, PhD, president and CEO of Seattle Genetics, said in a company-issued press release. “The [ECHELON-1] data demonstrated superior activity of the Adcetris-containing regimen over standard of care, and we are working with the FDA to make this bleomycin-free regimen available to newly diagnosed advanced Hodgkin lymphoma patients as soon as possible.”