CHMP recommends extension of approval of Adcetris in CD30+ Stage IV Hodgkin lymphoma.- Takeda.

Takeda Pharmaceutical announced that the European Medicines Agency�s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for the extension of the marketing authorization of Adcetris (brentuximab vedotin) and recommended its approval in combination with Adriamycin, Vinblastine and Dacarbazine (AVD) in adult patients with previously untreated CD30+ Stage IV Hodgkin lymphoma.

The positive CHMP opinion is based on the results of the Phase III ECHELON-1 study designed to compare Adcetris plus AVD to ABVD as a therapy in adult patients with previously untreated Hodgkin lymphoma. The trial achieved its primary endpoint resulting in a statistically significant improvement in modified progression-free survival (PFS) versus the control arm (HR 0.77; p-value=0.035). Key subgroup analyses, such as modified PFS by disease stage, showed a larger effect in patients with Stage IV Hodgkin lymphoma in the Adcetris plus AVD arm versus the control arm (HR 0.71; p-value = 0.023). This corresponds to a 29 percent reduction in the risk of progression, death or need for additional anticancer therapy for Stage IV patients.