The European Commission (EC) has expanded the marketing authorisation of Takeda Pharmaceutical’s Adcetris (brentuximab vedotin) to adults with previously untreated CD30+ Stage IV Hodgkin lymphoma.
The indication covers use in combination with adriamycin, vinblastine and dacarbazine (AVD).
Adcetris is an antibody-drug conjugate (ADC) targeting CD30, a significant marker of Hodgkin lymphoma. It is based on Seattle Genetics’ technology.
The EC authorisation is based on data obtained during the Phase III ECHELON-1 clinical trial that compared Adcetris in combination with AVD to Adriamycin, bleomycin, vinblastine and dacarbazine (ABVD).
The randomised, open-label, two-arm, multi-centre study met its primary endpoint with a statistically significant improvement in modified progression-free survival (PFS), demonstrating a 23% decrease in the risk of progression, death or need for additional therapy.
In addition, the safety profile of the investigational combination was observed to be generally consistent with the individual profiles of the drugs.
The most common clinically relevant adverse events observed during the trial were neutropenia, constipation, vomiting, fatigue, peripheral sensory neuropathy, diarrhoea, pyrexia, peripheral neuropathy, abdominal pain and stomatitis.
Takeda Pharmaceutical vice-president and Oncology Clinical Research and Development head Jesús Gómez-Navarro said: “We are pleased that the European Commission has approved Adcetris in combination with AVD, which has the potential to represent an important milestone for patients and serves as a testament to Takeda’s longstanding commitment to the Hodgkin lymphoma community.
“The ECHELON-1 clinical trial demonstrated that the addition of Adcetris and the removal of bleomycin from the standard ABVD regimen yielded both efficacy and safety benefits in patients.”
In Europe, the drug also holds approval for relapsed or refractory CD30+ Hodgkin lymphoma, relapsed or refractory systemic anaplastic large cell lymphoma (sALCL) and CD30+ cutaneous T-cell lymphoma (CTCL).