Supplemental FDA Application for Lymphoma Drug Adcetris

Seattle Genetics announced that it has submitted a supplemental Biologics License Application (sBLA) to the FDA supporting the use of Adcetris (brentuximab vedotin) for the retreatment and extended duration beyond 16 cycles of therapy in relapsed Hodgkin lymphoma (HL) and systemic anaplastic large cell lymphoma (sALCL).

The sBLA submission is based on results from a Phase 2 clinical trial with two treatment arms. One arm evaluated retreatment with Adcetris in patients who previously responded to treatment with Adcetris, then discontinued treatment leading to disease progression or relapse. The other arm allowed treatment extension and evaluated prolonged treatment with Adcetris beyond 16 cycles of therapy. The sBLA submission includes updated data sets from this Phase 2 trial.

Adcetris is a CD30-directed antibody-drug conjugate already indicated for the treatment of Hodgkin lymphoma after failure of autologous stem cell transplant (ASCT) or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not ASCT candidates. Adcetris is also indicated for the treatment of systemic anaplastic large cell lymphoma after failure of at least one prior multi-agent chemotherapy regimen.

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