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CHMP Recommends Takeda's Adcetris, Chemo for CD30-Positive Stage III Hodgkin Lymphoma

NEW YORK – Takeda said on Monday the European Medicine Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended approval for Adcetris (brentuximab vedotin) plus chemo as a first-line treatment for CD30-positive stage III Hodgkin lymphoma.

The positive recommendation was based on data from the Phase III ECHELON-1 trial that compared Adcetris plus doxorubicin, vinblastine, and dacarbazine chemo to doxorubicin, bleomycin, vinblastine, and dacarbazine. The latest results from the ECHELON-1 trial with five years of follow-up found that 93.9 percent of patients in the Adcetris-chemo arm were alive at six years compared to 89.4 percent in the chemo-alone arm. The six-year progression-free survival rate was also higher in the Adcetris-chemo arm versus chemo alone, 82.3 percent compared to 74.5 percent, respectively.

Takeda noted that the ECHELON-1 trial met its key primary and second endpoints including both progression-free and overall survival.

The submission will now be reviewed by the European Commission for potential approval in Europe. Adcetris is already approved in Europe for other CD30-positive Hodgkin and non-Hodgkin lymphomas, including previously treated stage IV Hodgkin lymphoma, untreated cutaneous T-cell lymphoma, and previously treated systemic anaplastic large cell lymphoma.

Adcetris plus chemo was approved in the US in November for the same indication of previously untreated CD30-positive stage III Hodgkin lymphoma based on the ECHELON-1 data. The drug is also approved for Hodgkin lymphoma and systemic anaplastic large cell lymphoma patients who have received prior treatment.

The drug is being jointly developed by Takeda and Seagen. Under the collaboration agreement, Seagen has commercialization rights in the US and Canada while Takeda holds commercial rights for the rest of the world.