Adcetris is an antibody-drug conjugate (ADC) with an anti-CD30 antibody, which in combination with doxorubicin, vinblastine and dacarbazine (AVD) is indicated for previously untreated adult patients with CD30+ Stage III Hodgkin lymphoma
EC expands approval for Takeda’s Adcetris plus AVD combination. (Credit: Christina Victoria Craft on Unsplash)
Takeda has received the European Commission (EC) approval for Adcetris (brentuximab vedotin) in combination with doxorubicin, vinblastine and dacarbazine (AVD) to treat CD30+ Stage III Hodgkin lymphoma in previously untreated adult patients.
Adcetris is an antibody-drug conjugate (ADC) with an anti-CD30 antibody attached to a microtubule-disrupting agent monomethyl auristatin E (MMAE).
The drug has been approved in Europe, as a treatment for adult patients in six distinct indications, including those with previously untreated CD30+ Stage IV Hodgkin lymphoma.
The expanded EC approval follows a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP).
Adcetris is not advised for patients with hypersensitivity to brentuximab vedotin and its excipients, and its use together with bleomycin causes pulmonary toxicity.
Takeda oncology global medical affairs head Awny Farajallah said: “We are thrilled with the decision of the European Commission to approve ADCETRIS in combination with chemotherapy as a treatment for adult patients with previously untreated CD30+ Stage III Hodgkin lymphoma, particularly as up to one-third of patients with Stage III & IV disease are at risk of experiencing treatment failure with current regimens.
“These patients now have ADCETRIS as a treatment option, and the significant improvement in survival outcomes that ADCETRIS may provide when added to a frontline treatment regimen, as evidenced by the ECHELON-1 clinical trial data.”
The expanded EC approval is based on results from the Phase 3 ECHELON-1 trial, which evaluated Adcetris plus AVD compared to ABVD in 1,334 patients with previously untreated Stage III or IV classical Hodgkin lymphoma.
ABVD is a combination of doxorubicin, bleomycin, vinblastine, and dacarbazine.
The Phase 3 clinical study met its primary endpoint of modified progression-free survival (PFS), and a key secondary endpoint of overall survival (OS).
In the study, the combination treatment showed a statistically significant improvement in OS in adult patients with previously untreated Stage III or IV classical Hodgkin lymphoma.
Adcetris showed a safety profile that was consistent with previous studies, with no new safety signals observed, said the Japanese drugmaker.
ECHELON-1 trial lead investigator John Radford said: “ECHELON-1 is the first trial to show a statistically significant improvement in overall survival outcomes for adult patients with Stage III & IV Hodgkin lymphoma in two decades, demonstrating the benefit ADCETRIS continues to bring to a broad group of patients.
“This approval is an exciting advancement in care, allowing even more lymphoma patients to access the proven efficacy, consistent safety, and tolerability that ADCETRIS is known to deliver.”