European regulators have approved Takeda's Adcetris (brentuximab vedotin) for use in adults with previously untreated systemic anaplastic large cell lymphoma (sALCL) in combination with CHP (cyclophosphamide, doxorubicin, prednisone).
Adcetris is the first and only targeted therapy approved in first-line sALCL for several decades bringing a new treatment option to those living with this type of peripheral T-cell lymphoma (PTCL).
The approval is based on results of the Phase III ECHELON-2 study, which met its primary endpoint with Adcetris plus CHP demonstrating a statistically significant improvement in progression-free survival (PFS) compared to standard treatment with CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone).
According to the firm, the safety profile of the combination observed in the trial was comparable to the standard of care and consistent with the established safety profile.
“Clinical outcomes for patients with sALCL have historically been poor; many patients do not achieve long-term survival or remission with the standard of care,” said Eva Domingo-Domenech, MD, Institut Català d'Oncologia – Hospitalet, Hospital Duran i Reynals.
“The data from ECHELON-2 showed impressive results for patients treated with Adcetris plus CHP compared to a standard of care, all while maintaining a comparable safety profile.
“The approval of Adcetris in previously untreated sALCL brings a much needed treatment option to the PTCL community, and I am pleased to be able to offer Adcetris as a first-line option to eligible European patients.”