Posted by Michael Wonder on 16 Nov 2018
FDA grants breakthrough therapy designation to Adcetris (brentuximab vedotin) for frontline peripheral T-cell lymphomas
15 November 2018 - Designation based on positive Phase 3 ECHELON-2 Trial evaluating Adcetris in frontline CD30-expressing peripheral T-cell lymphomas.
Seattle Genetics today announced that the U.S. FDA has granted breakthrough therapy designation to Adcetris (brentuximab vedotin) for previously untreated systemic anaplastic large cell lymphoma or other CD30-expressing peripheral T-cell lymphomas (PTCL), including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified, in combination with CHP (cyclophosphamide, doxorubicin, and prednisone).
The positive top-line results of the phase 3 ECHELON-2 clinical trial were announced in October 2018, followed by the submission of a supplemental biologics license application to the FDA in November 2018.
