The US Food and Drug Administration (FDA) has accepted filing of a supplemental biologics licence application (sBLA) by Seattle Genetics for its ADCETRIS (brentuximab vedotin) in combination with chemotherapy as frontline treatment of advanced classical Hodgkin lymphoma.
The agency has granted priority review for the filing, and the Prescription Drug User Fee Act (PDUFA) target action date is 1 May.
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Currently being assessed in 70 clinical trials, ADCETRIS is a monoclonal antibody-drug conjugate (ADC) designed to target CD30, which is considered as a defining marker of the disease.
The sBLA submission is based on positive data obtained during the Phase III ECHELON-1 trial that aimed to establish the ability of ADCETRIS and chemotherapy combination to extend modified progression-free survival in 1,334 previously untreated patients with advanced classical Hodgkin lymphoma.
ECHELON-1 is reported to have met the primary endpoint, along with favourable secondary endpoints and consistent safety profile compared to the single-agent components of the combination.
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.
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By GlobalData“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 firm is co-developing ADCETRIS with Takeda and has commercialisation rights in the US and Canada, while the latter holds rights in all the remaining countries.
