TOC
【FDA Approval Alert】Seagen’s brentuximab vedotin combination Approved for Relapsed/Refractory Large B-Cell Lymphoma (LBCL) (February 11, 2025)
On February 11, 2025, the U.S. FDA granted accelerated approval to brentuximab vedotin (Adcetris) + lenalidomide + rituximab for adult patients with relapsed or refractory large B-cell lymphoma (LBCL) after at least one prior therapy. Approval was based on the STARGLO trial (NCT04404283).
Disease Overview: Large B-Cell Lymphoma (LBCL)
LBCL is the most common subtype of non-Hodgkin lymphoma. Treatment options for relapsed or refractory disease are evolving, targeting pathways such as CD30, CD20, and immune modulation.
Treatment Summary
- Drug Name: brentuximab vedotin + lenalidomide + rituximab
- Company: Seagen Inc. (now part of Pfizer)
- Approval Date: February 11, 2025
- Indication: Relapsed/Refractory LBCL (≥ second-line)
- Mechanism of Action: CD30 ADC + immunomodulator + anti-CD20 antibody
- Pivotal Trial: STARGLO (NCT04404283)
- Key Efficacy:
- Median OS: 22.5 vs 16.3 months (HR 0.61; p=0.0144)
- ORR: 73% vs 50% (CR rate: 59% vs 27%)
Patient-Friendly Summary
This combination attacks lymphoma cells through multiple mechanisms, providing a new treatment option for patients with relapsed/refractory disease.
M&A Information
- Subsidiary: Seagen Inc. (acquired by Pfizer)
- Acquisition Date: 2023
- Development Stage at Acquisition: Phase 3
- Investor Information: Public Investors (NYSE: PFE)
Source
This approval information is based on data from Drugs@FDA (U.S. FDA) and AACR releases.
