Takeda Pharmaceutical Company Limited announced that the European Commission (EC) extended the current conditional marketing authorization of ADCETRIS® (brentuximab vedotin) to include treatment of adult patients with previously untreated systemic anaplastic large cell lymphoma (sALCL), in combination with CHP (cyclophosphamide, doxorubicin, prednisone).
Systemic anaplastic large cell lymphoma is a subtype of peripheral T-cell lymphoma (PTCL).
Teresa Bitetti, President, Global Oncology Business Unit
“ADCETRIS is the first and only targeted therapy that has been approved in first-line sALCL in several decades.”
This approval is based on the results of the Phase 3 ECHELON-2 study evaluating ADCETRIS in combination with CHP to a standard of care, CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone), in patients with CD30+ PTCL, including the subtype sALCL. The study met its primary endpoint with ADCETRIS plus CHP demonstrating a statistically significant improvement in progression-free survival (PFS) in the intent to treat population as assessed by an Independent Review Committee (hazard ratio [HR]=0.71; p-value=0.0110). The safety profile of ADCETRIS plus CHP in the ECHELON-2 trial was comparable to CHOP and consistent with the established safety profile of ADCETRIS in combination with chemotherapy.