The European Commission (EC) has approved a Type II variation on the labels of Adcetris (brentuximab vedotin).
The new labels will include re-treatment data for adult patients who have relapsed after initially successful treatment with Adcetris. The information is specifically for treatment of relapsed or refractory Hodgkin lymphoma or systemic anaplastic large cell lymphoma (sALCL).
“Adcetris has transformed the treatment landscape for relapsed/refractory Hodgkin lymphoma and sALCL patients in Europe and has emerged as a most valuable tool to induce a remission,” University of Amsterdam Professor of Hematology Dr. Anton Hagenbeek said. “However, lymphoma is a relentless disease, and relapse occurs in some of these very difficult to treat patients. Now, with the opportunity for re-treatment, we can offer patients with very limited options another chance to potentially benefit from Adcetris.”
The decision was made based on the favorable results of a Phase II study designed to evaluate Adcetris re-treatment in patients who had relapsed. The study's primary goals were safety and anti-tumor response, with secondary objectives of lengthening tumor control, progression-free survival and overall survival.
After receiving a positive opinion from the Committee for Medicinal Products for Human Use (CHMP), the EC approved the label variation.
“The EC decision to include data on re-treatment in the Adcetris label is important in advancing care for patients battling these diseases,” Takeda Executive Medical Director Dr. Dirk Huebner said. “We look forward to continuing our ongoing clinical program of Adcetris in Hodgkin lymphoma and sALCL, as well as in a variety of other forms of lymphoma, with the goal of bringing this important therapy to patients who might benefit from it.”
