New FDA approval for Pfizer’s Adcetris

13 February 2025

The US Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for Adcetris (brentuximab vedotin) in yet another indication, US pharma giant Pfizer (NYSE: PFE) announced late yesterday.

This is for Adcetris in combination with lenalidomide and a rituximab product for the treatment of adult patients with relapsed or refractory large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), DLBCL arising from indolent lymphoma, or high-grade B-cell lymphoma (HGBL), after two or more lines of systemic therapy who are not eligible for autologous hematopoietic stem cell transplantation (auto-HSCT) or chimeric antigen receptor (CAR) T-cell therapy.

The drug is now authorized for eight indications in the USA, including B-cell lymphoma (BCL) and Hodgkin lymphoma (cHL).

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