FDA Approves Pfizer’s Adcetris Combination Therapy for Relapsed/Refractory Large B-cell Lymphoma
The FDA approved Adcetris (brentuximab vedotin) in combination with lenalidomide and rituximab for treating relapsed or refractory large B-cell lymphoma (LBCL)13.
The approval is for adult patients who have received at least two prior lines of systemic therapy and are ineligible for autologous hematopoietic stem cell transplantation or CAR T-cell therapy36.
The approval was based on the Phase 3 ECHELON-3 study, which demonstrated a 37% reduction in the risk of death compared to placebo with lenalidomide and rituximab26.
Median overall survival improved from 8.5 months to 13.8 months with the Adcetris combination therapy6.
This marks Adcetris' expansion into non-Hodgkin lymphomas, adding to its existing approvals for other types of lymphomas7.
Adcetris is an antibody-drug conjugate (ADC) that targets CD30-expressing tumor cells34.
The approval provides a new treatment option for patients with LBCL who have limited alternatives after failing previous therapies7.
This is the third Phase 3 trial demonstrating improved overall survival with an Adcetris-containing regimen in different types of lymphoma2.
Sources:
1. https://www.fiercepharma.com/pharma/pfizers-blockbuster-adc-adcetris-nabs-fda-approval-treat-large-b-cell-lymphoma
2. https://www.pfizer.com/news/press-release/press-release-detail/pfizers-adcetrisr-regimen-produces-clinically-meaningful
3. https://www.lymphoma.org/news/the-u-s-food-and-drug-administration-fda-approves-brentuximab-vedotin-with-lenalidomide-and-rituximab-for-relapsed-or-refractory-large-b-cell-lymphoma/
4. https://pmlive.com/pharma_news/pfizer-granted-fda-approval-for-adcetris-combination-in-large-b-cell-lymphoma/
6. https://ascopost.com/news/february-2025/fda-approves-brentuximab-vedotin-with-lenalidomide-and-rituximab-for-relapsed-or-refractory-lbcl
7. https://www.biospace.com/fda/pfizer-continues-cancer-rally-as-adectris-label-expands-to-non-hodgkin-lymphomas