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Brentuximab vedotin (Adcetris®) supplemental BLA has been accepted by FDA for advanced HL
On 2nd January 2018, SeattleGenetics announced in a press release that the U.S. food and drug administration (FDA) has accepted a supplemental Biologics License Application (BLA) for brentuximab vedotin (Adcetris®) in combination with chemotherapy for the frontline treatment of patients with advanced classical Hodgkin lymphoma (HL).
The FDA decision was based on clinical trial results of the ECHELON-1 study that were presented at the 59th ASH Annual Meeting and Exhibition in Atlanta, GA, December 2017. The phase III study was international, open-label, randomized and multicenter and compared brentuximab vedotin plus AVD (doxorubicin, vinblastine, and dacarbazine) with ABVD as frontline therapy in patients with stage III or IV classic Hodgkin’s lymphoma. The trial results showed that A+AVD had significantly superior modified progression-free survival.
In an interview at the ASH annual meeting 2017 with Anas Younes, University Professor at the Weill-Cornell Medical College, he noted that "for North America ABVD is still the standard of care," and that alternative options may be limited. He added that "having a new option with brentuximab plus AVD is a good step forward but still more work needs to be done."