The European Medicines Agency’s Committee for Medicinal Products for Human Use granted a positive opinion for the extension of the marketing authorization of Adcetris (brentuximab vedotin) and recommended its approval in combination with CHP (cyclophosphamide, doxorubicin, prednisone) as a treatment for adult patients with previously untreated systemic anaplastic large cell lymphoma.
Takeda Pharmaceutical Company Ltd. sponsors Adcetris.
The positive CHMP opinion is based on the results of the phase III ECHELON-2 study evaluating Adcetris in combination with CHP to a standard care, CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone), in previously untreated patients with CD30+ peripheral T-cell lymphoma, including the subtype sALCL. Adcetris is an antibody-drug conjugate directed at CD30, which is expressed on the surface of several types of PTCL, including sALCL.
“There have been no significant treatment advancements for PTCL over the last few decades. Historically there have been a lack of randomized clinical studies in this setting, making it a challenge to establish an optimal therapy for these patients,” Eva Domingo-Domenech,Institut Català d’Oncologia – Hospitalet, Hospital Duran i Reynals, said in a statement. “Outcomes with currently available therapies are often poor, and there is an urgent need for new treatment options. If approved for adult patients with previously untreated sALCL, ADCETRIS may offer an important option for European patients.”
“ECHELON-2 showed that Adcetris plus CHP demonstrated a significant improvement in progression-free survival and overall survival while maintaining a safety profile comparable to the standard of care of CHOP,” Christopher Arendt, head of the Oncology Therapeutic Area Unit at Takeda, said in a statement.
The opinion for Adcetris will now be reviewed by the European Commission for Commission Decision. Adcetris is not approved as a therapy for frontline sALCL in Europe.
The ECHELON-2 study met its primary endpoint with Adcetris plus CHP demonstrating a statistically significant improvement in progression-free survival as assessed by an Independent Review Committee (hazard ratio [HR]=0.71; p-value=0.0110), 29% improvement in PFS. 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.
