Posted by Michael Wonder on 23 Jan 2018
Seattle Genetics announces Adcetris (brentuximab vedotin) receives European Commission approval for CD30-positive cutaneous T-cell lymphoma after at least one prior systemic therapy
22 January 2018 - Approval based on positive Phase 3 ALCANZA trial results, which demonstrated a highly statistically significant improvement in rate of objective response lasting at least four months, median progression-free survival, and improvement in symptom burden in Adcetris arm.
Seattle Genetics reported today that its collaborator, Takeda Pharmaceutical Company Limited, announced that the European Commission has extended the current conditional marketing authorisation for Adcetris (brentuximab vedotin) to include the treatment of adult patients with CD30-positive cutaneous T-cell lymphoma after at least one prior systemic therapy.
The decision follows a positive opinion from the CHMP on 9 November 2017.
