Research & Development
US FDA receives supplemental Biologics License Application for Seattle Genetics' Adcetris
7 November 2018 -

The US Food and Drug Administration (FDA) has received a supplemental Biologics License Application from United States-based Seattle Genetics, seeking approval for its Adcetris (brentuximab vedotin) in combination with chemotherapy intended for the frontline treatment of CD30-expressing peripheral T-cell lymphoma, it was reported yesterday.

The company is seeking approval for the product based on data from the phase three ECHELON-2 trial. The product is an antibody-drug conjugate directed to CD30, which is expressed on the surface of several types of peripheral T-cell lymphoma. It is currently not approved for the frontline treatment of peripheral T-cell lymphoma.

The phase 3 ECHELON-2 clinical trial assessed the combination of the product plus CHP (cyclophosphamide, doxorubicin, prednisone) compared to a recognised standard of care chemotherapy regimen, CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone), in earlier untreated CD30-expressing PTCL. Thestudy met its primary endpoint demonstrating a statistically significant improvement in progression-free survival (PFS) as assessed by an Independent Review Facility (IRF; hazard ratio=0.71; p-value=0.0110).

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