Seattle Genetics wins third Breakthrough designation for Adcetris
Seattle Genetics (Nasdaq: SGEN) has been given Breakthrough Therapy designation from the US Food and Drug Administration for Adcetris (brentuximab vedotin) for certain peripheral T-cell lymphomas (PTCL).
The designation applies to first-line treatment of systemic anaplastic large cell lymphoma or other CD30-expressing PTCL, in combination with chemo.
The firm announced positive Phase III data from the ECHELON-2 trial of the antibody-drug conjugate last month, and recently applied to extend the label for the therapy in this indication.
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