Pfizer Reports the US FDA Approval of Adcetris Regimen to Treat R/R Diffuse Large B-Cell Lymphoma (DLBCL)
Shots:
- The US FDA has approved sBLA for Adcetris + lenalidomide + Rituxan to treat adults with r/r LBCL (incl. DLBCL NOS, indolent lymphoma associated DLBCL, or HGBL), previously treated with ≥2L of therapy & are not eligible for auto-HSCT or CAR-T therapy
- Approval was based on P-III (ECHELON-3) trial assessing Adcetris with lenalidomide + Rituxan (R2) vs PBO + R2 in r/r DLBCL pts (n=230), irrespective of CD30 expression in North America, EU & APAC
- Study showed 37% reduction in death risk & consistent OS across all CD30 expression levels with improvements in 2EPs (ORR & PFS); data was presented in ASCO 2025 & was published in The JCO
Ref: Pfizer | Image: Pfizer
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