Seattle Genetics announced that the Food and Drug Administration (FDA) has approved Adcetris (brentuximab vedotin) for Injection for the treatment of patients with classic Hodgkin lymphoma (HL) at high risk of relapse or progression post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation.

The FDA approval is based on data from AETHERA, a Phase 3 trial that compared up to 16 cycles (approximately one year) of Adcetris therapy given every three weeks after auto-HSCT vs. placebo. The primary endpoint was improvement in median progression-free survival (PFS). Patients in the Adcetris group had a median PFS of 42.9 months (95% CI: 30.4, 42.9) vs. 24.1 months (95% CI: 11.5, not estimable) for patients in the placebo group; this was an improvement of 18.8 months (HR 0.57, 95% CI: 0.40, 0.81; P=0.001).

Adcetris is an antibody-drug conjugate (ADC) directed to CD30, which is expressed in classical HL and systemic anaplastic large cell lymphoma (sALCL), as well as other lymphoma subtypes. The anticancer activity of Adcetris is due to the binding of the ADC to CD30-expressing cells, followed by internalization of the ADC-CD30 complex, and the release of MMAE via proteolytic cleavage.

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Adcetris is already indicated for the treatment of Hodgkin lymphoma patients who fail autologous transplant or who fail at least two prior multi-agent chemotherapy regimens and are not autologous transplant candidates; and for the treatment of systemic ALCL patients who fail at least one prior multi-agent chemotherapy regimen.

Adcetris is available as a 50mg strength powder in single-use vials.

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