Pfizer has announced that the US Food and Drug Administration (FDA) has approved a supplemental biologics license application (sBLA) for Adcetris (brentuximab vedotin) to treat certain adult patients with lymphoma.
ADCETRIS, in combination with lenalidomide and rituximab, is now approved for relapsed or refractory large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL), DLBCL arising from an indolent lymphoma, and high-grade B-cell lymphoma (HGBL).
The treatment is indicated for patients who have not responded to two or more prior therapies and are ineligible for autologous stem cell transplantation (auto-HSCT) or chimeric antigen receptor (CAR) T-cell therapy.
This milestone marks the eighth FDA-approved indication for brentuximab vedotin.
The FDA’s latest approval is based on positive efficacy and safety results from the Phase 3 ECHELON-3 study.
The late-stage trial demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) for patients with relapsed/refractory DLBCL treated with ADCETRIS combined with lenalidomide and rituximab.
It included heavily pre-treated patients, some of whom had previously undergone CAR-T therapy. The survival benefit was observed regardless of CD30 expression.
The ECHELON-3 study showed that the ADCETRIS combination reduced the risk of death by 37% compared to placebo plus lenalidomide and rituximab.
Positive results were also seen in secondary endpoints, including overall response rate (ORR) and progression-free survival (PFS).
The safety profile of ADCETRIS in ECHELON-3 was consistent with its established safety data. Pfizer chief oncology officer Roger Dansey said: “Each year, more than 3,500 patients in the US with this aggressive form of non-Hodgkin lymphoma experience treatment failure or relapse after two prior lines of therapy.
“Today’s approval further reinforces the important role of ADCETRIS as an existing standard of care with overall survival improvement shown for certain types of lymphomas, and now allows physicians to have an option beyond chemotherapy or CAR-Ts for patients with relapsed/refractory large B-cell lymphoma.”
Pfizer and Takeda have jointly developed brentuximab vedotin. Under their collaboration agreement, Pfizer holds US and Canadian commercialisation rights, while Takeda has global rights outside of these regions. In June last year, Pfizer and Takeda announced that the Phase 3 HD21 trial evaluating an additional ADCETRIS combination in frontline Hodgkin lymphoma had shown positive results.
