The FDA is likely to take a call on Adcetris approval by 1 May 2018 as per the Prescription Drug User Fee Act (PDUFA).
Seattle Genetics’ supplemental BLA was based on the positive findings of the ECHELON-1 phase 3 trial which met its primary endpoint.
Adcetris in combination with chemotherapy succeeded in delivering a significant improvement in modified progression-free survival (PFS) in patients with advanced classical Hodgkin lymphoma who did not receive any prior treatment,in comparison with a recognized standard of care chemotherapy regimen, ABVD (Doxorubicin, Bleomycin, Vinblastine, Dacarbazine).
Adcetris was evaluated in combination with AVD (Adriamycin, vinblastine, dacarbazine) chemotherapy during the late-stage trial.
Seattle Genetics president and CEO Clay Siegall said: “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.
“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.”
The priority review of Adcetris follows its breakthrough therapy designation which was granted by the FDA in October 2017, with an intention to accelerate the drug’s development and its possible launch for patients in need of new treatment options.
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.