FDA approves Adcetris (brentuximab vedotin) with combination chemotherapy for advanced stage classical HL

On 20 March 2018, the US Food and Drug Administration (FDA) granted approval of Seattle Genetics’ Adcetris (brentuximab vedotin) in combination with chemotherapy, for the treatment of adults with previously untreated Stage III or IV classical Hodgkin lymphoma (cHL).

The FDA approval was based on the successful results from the multicenter, open-label, randomized ECHELON-1 phase III clinical trial (NCT01712490). In this study, brentuximab vedotin in combination with doxorubicin, vinblastine, and dacarbazine (A+AVD) was compared to AVD plus bleomycin (ABVD), as a regimen for advanced stage cHL patients. Superior efficacy of A+AVD was reported with a significantly lower combined risk of progression, as compared to ABVD.

The FDA had granted this application Priority Review and Breakthrough Therapy designation. According to Richard Pazdur, Director of the FDA Oncology Center of Excellence “Today’s approval represents an improvement in the initial treatment regimens of advanced HL that were introduced into clinical practice more than 40 years ago”.

In an interview we conducted at ASH 2017, Atlanta, GA, Professor Anas Younes from the Weill-Cornell Medical College, discussed the ECHELON-1 results and how they impact the current standard of care for advanced-stage HL patients.

  1. FDA. FDA expands approval of Adcetris for first-line treatment of Stage III or IV classical HL in combination with chemotherapy. 2018 Mar 20. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm601935.htm [Accessed 2018 Mar 21]
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