CHMP positive recommendation for Adcetris (brentuximab vedotin) + BrECADD chemotherapy to treat Stage IIb with risk factors/III/IV Hodgkin lymphoma.. Takeda + Pfizer

Takeda  announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for the extension of the marketing authorization of Adcetris  (brentuximab vedotin) and recommended its approval in combination with etoposide, cyclophosphamide, doxorubicin, dacarbazine and dexamethasone (BrECADD), a chemotherapy regimen, in adult patients with newly diagnosed Stage IIb with risk factors/III/IV Hodgkin lymphoma.

The marketing authorization application for Adcetris  will now be reviewed by the European Commission (EC), which has the authority to approve medicines for use in the 27-member states of the European Union. Decisions by the EC are also applicable in Norway, Liechtenstein and Iceland.

The positive CHMP opinion is based on the results of the randomized Phase III HD21 trial, which is designed to evaluate Adcetris in combination with ECADD in comparison to a standard of care treatment predominantly used in Europe  – escalated doses of bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, prednisone (eBEACOPP) – in patients with newly diagnosed Stage IIb/III/IV Hodgkin lymphoma. The study, sponsored by the German Hodgkin Study Group (GHSG) and supported by Takeda, met its co-primary endpoints, with the Adcetris  + ECADD combination regimen demonstrating significantly improved safety as assessed by treatment-related morbidity (TRMB) and non-inferior progression-free survival (PFS).