The U.S. Food and Drug Administration (FDA) has agreed to review Adcetris (brentuximab vedotin) in combination with chemotherapy as a frontline treatment for patients with advanced Hodgkin’s lymphoma, according to Seattle Genetics.
The supplemental Biologics License Application was granted priority review, which shortens a drug’s review time from 10 to six months. A decision by the FDA is expected by May 1.
“The FDA’s filing of our supplemental BLA 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 press release.
The application is based on the positive results of the ECHELON-1 Phase 3 trial (NCT01712490). The study investigated whether Adcetris plus chemotherapy extended the modified progression-free survival (modified PFS) in treatment-naïve patients with advanced Hodgkin’s lymphoma.
Modified PFS was defined as the time to disease progression, death, or administration of additional therapy for patients who are not in complete remission after completing first-line therapy.
Participants were randomized to receive either Adcetris plus standard of care chemotherapy – adriamycin, vinblastine, dacarbazine (AVD) – or chemotherapy plus bleomycin.
Patients treated with the Adcetris combo had a 23% reduction in the risk of disease progression, death, or need for additional therapy. At two years, the modified PFS was 82.1% in the Adcetris arm, compared to 77.2% in the control arm (chemo plus bleomycin).
Secondary endpoints – overall survival, complete remission, and safety – were also met, with Adcetris treatment showing better results than the control. The safety profile of Adcetris plus chemotherapy was similar to that described for each agent alone.
In December 2017, Seattle Genetics and Takeda Pharmaceuticals, presented the latest data from ECHELON-1 during the the 59th American Society of Hematology (ASH) Annual Meeting in Atlanta.
Results were simultaneously published in The New England Journal of Medicine, in the study, “Brentuximab Vedotin with Chemotherapy for Stage III or IV Hodgkin’s Lymphoma.”
“We recently reported the primary data from the phase 3 ECHELON-1 clinical trial in the Plenary Scientific Session of the 2017 ASH Annual Meeting with simultaneous publication in the New England Journal of Medicine,” Siegall said.
“The 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,” he added.
Adcetris is FDA-approved for four lymphoma indications in the U.S. It is also approved in Canada for several lymphomas, and has received conditional approvals in the European Union for certain Hodgkin’s lymphomas.