Regulatory Affairs

FDA expands approval of Seattle Genetics’ Adcetris for advanced classical Hodgkin Lymphoma

PBR Staff Writer Published 21 March 2018

Seattle Genetics’ Adcetris (Brentuximab Vedotin) in combination with chemotherapy has been approved by the US Food and Drug Administration (FDA) to treat adult patients with previously untreated stage III or IV classical Hodgkin lymphoma (cHL).

Adcetris is an antibody-drug conjugate (ADC) that allows the antibody to direct the drug to a target on lymphoma cells known as CD30, which is considered to be a marker of cHL.

Previously, Adcetris was approved by the FDA for the treatment of cHL after relapse, cHL following stem cell transplant in patients at high risk of relapse or progression, systemic anaplastic large cell lymphoma (ALCL) after failure of other treatment, and primary cutaneous ALCL after failure of other treatment.

FDA Oncology Center of Excellence director Richard Pazdur said: “Today’s approval represents an improvement in the initial treatment regimens of advanced Hodgkin lymphoma that were introduced into clinical practice more than 40 years ago.”

“This approval demonstrates our commitment to approving advancements in treatment that give prescribers and patients different options for care.”

Adcetris’ FDA approval for stage III or IV cHL is based on the positive results of the phase 3 ECHELON-1 clinical trial, which evaluated the drug in combination with AVD chemotherapy made up of Adriamycin, vinblastine and dacarbazine to ABVD, a standard of care chemotherapy regimen made up of Adriamycin, bleomycin, vinblastine and dacarbazine.

The trial held in 1,334 stage III or IV cHL patients achieved its primary endpoint with the Adcetris combination with AVD bringing in a statistically significant improvement in modified progression-free survival (PFS) in comparison with the ABVD treatment.

Seattle Genetics president and CEO Clay Siegall said: “The ECHELON-1 trial was a bold, five-year effort to redefine the frontline treatment of Stage III/IV classical Hodgkin lymphoma and provide patients with a more effective treatment regimen.

“In the ECHELON-1 study, ADCETRIS plus AVD was shown to have superior efficacy to ABVD. With today’s FDA approval, the physician and patient community have a new treatment option for previously untreated Stage III or IV Hodgkin lymphoma patients.”


Image: FDA Building 51 in Silver Spring, Maryland which houses the Center for Drug Evaluation and Research. Photo: courtesy of The U.S. Food and Drug Administration/Wikipedia.org.