EC expands Takeda’s Adcetris label for advanced Hodgkin lymphoma treatment
The European Commission (EC) has approved Seagen and Takeda Pharmaceuticals’ Adcetris (brentuximab vedotin)/chemotherapy combination as a first-line treatment for patients with previously untreated Stage III Hodgkin lymphoma (HL). Adcetris, an antibody-drug conjugate (ADC) therapy, will be used simultaneously with doxorubicin, vinblastine, and dacarbazine (AVD) to target CD30 in Reed Sternberg cells, a key marker that differentiates HL from other lymphomas. The intravenously administered drug is designed to block cancer cell proliferation by binding a monomethyl auristatin E (MMAE)-carrying monoclonal antibody to CD30 and releasing the cytotoxin into tumour cells, thereby inducing cell death. The EC approval was based on results from the Phase III ECHELON-1 (NCT01712490) study, a randomised, open label, multi-centre clinical trial comparing Adcetris/AVD’s effectiveness at treating advanced HL versus doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) in 1,334 patients. The study met its primary endpoint of modified progression-free survival (mPFS) as determined by an independent review facility (IRF). Secondary endpoints were also observed. The improvements in overall survival (OS), as per the company, were “statistically significant". The trial reported a consistent safety profile for the treatment. The drug combination approval follows a positive recommendation from the EU Committee for Medicinal Products for Human Use (CHMP) in September. The latest European approval marks another marketing authorization expansion for Adcetris, which was first approved in 2012. Adcetris is approved to treat six other indications in the European Union (EU). Takeda’s ADC is one of many in the rapidly growing global ADC market. According to GlobalData’s Pharmaceutical Intelligence Center, the ADC market saw a 400% growth in total licensing agreement deal value between 2017 and 2022, with total deal value peaking at $16.6bn in 2022. GlobalData is the parent company of Pharmaceutical Technology. Billion-dollar deals are becoming common in the ADC market and attracting big biopharmaceutical names. Earlier this year, Pfizer announced its plan to acquire Seagen for $43bn. In addition to the partnership with Takeda, ADC giant Seagen has advanced its own oncology ADC therapy portfolio by signing licencing agreements with heavy hitters MSD, Sanofi, BMS, and AbbVie.
Adcetris/AVD is already approved as a first-line treatment for patients with CD30+ Stage IV Hodgkin lymphoma.
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