CHMP recommends extension of approval for Adcetris plus CHP in anaplastic large cell lymphoma.- Takeda Pharma

Takeda Pharmaceutical Co announced that 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 (sALCL).

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 (PTCL), including the subtype sALCL. Adcetris is an antibody-drug conjugate (ADC) directed at CD30, which is expressed on the surface of several types of PTCL, including sALCL.

The ECHELON-2 study met its primary endpoint with Adcetris plus CHP demonstrating a statistically significant improvement in progression-free survival (PFS) as assessed by an Independent Review Committee (hazard ratio [HR]=0.71; p-value=0.0110), 29 percent 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.