Takeda’s Adcetris receives positive opinion for Hodgkin lymphoma treatment

CHMP recommendation brings new hope for patients

Takeda has announced a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) recommending European Commission (EC) approval of Adcetris (brentuximab vedotin) in combination with the BrECADD chemotherapy regimen for adults with newly diagnosed stage IIb with risk factors, stage III, or stage IV Hodgkin lymphoma.

The marketing authorisation application will now undergo review by the EC, which is expected to deliver a decision applicable across the 27 EU member states, as well as Norway, Liechtenstein and Iceland.

The recommendation is supported by phase 3 data from the HD21 trial, sponsored by the German Hodgkin Study Group and backed by Takeda. The trial evaluated ADCETRIS with BrECADD against the European standard of care, eBEACOPP.

Results showed significant improvement in safety as measured by treatment-related morbidity and non-inferior progression-free survival (PFS).

The HD21 trial enrolled patients with advanced Hodgkin lymphoma, including those with Stage IIb large mediastinal mass or extranodal lesions. Participants received two cycles of either escalated BEACOPP or BrECADD, followed by PET-adapted staging to guide subsequent treatment cycles.

The co-primary endpoints assessed safety, through treatment-related morbidity, and efficacy, through PFS. Secondary outcomes included overall survival, complete response rate, and quality of life measures.

Hodgkin lymphoma, characterised by Reed-Sternberg cells with CD30 protein, affects thousands globally. CD30 is targeted by ADCETRIS, an antibody-drug conjugate designed to selectively deliver treatment to tumour cells.

As of 2022, over 82,000 people worldwide were diagnosed with Hodgkin lymphoma, with approximately 23,000 deaths reported that year, according to the International Agency for Research on Cancer.

If approved, ADCETRIS would represent a significant advancement, offering an innovative treatment option for patients with advanced Hodgkin lymphoma.