The U.S. Food and Drug Administration (FDA) has approved Brentuximab vedotin in combination with lenalidomide and rituximab for the treatment of relapsed or refractory large B-cell lymphoma (LBCL) in patients who are ineligible for stem cell transplant or CAR T-cell therapy.
The U.S. Food and Drug Administration (FDA) has granted approval to Brentuximab vedotin in combination with lenalidomide and rituximab for the treatment of relapsed or refractory large B-cell lymphoma ( LBCL ) in patients who are ineligible for stem cell transplant or CAR T-cell therapy. This approval marks a significant advancement for patients with this aggressive form of cancer who lack access to these potentially curative therapies.
The FDA's decision is based on the results of a Phase III clinical trial involving 230 patients with diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), DLBCL arising from indolent lymphoma, or high-grade B-cell lymphoma (HGBL). Patients were randomly assigned to receive either lenalidomide and rituximab (R2) plus brentuximab vedotin (BV) or placebo (Pbo) until disease progression or unacceptable toxicity. The trial demonstrated a significant improvement in overall survival (OS) with BV+R2 compared to Pbo+R2, with a median OS of 13.8 months versus 8.5 months, respectively (hazard ratio, 0.63). The benefit in OS was consistent across different levels of CD30 expression, a protein often found on the surface of lymphoma cells. Additionally, BV+R2 showed a longer median progression-free survival (PFS) of 4.2 months compared to 2.6 months with Pbo+R2 (hazard ratio, 0.53), and a significantly higher objective response rate (ORR) of 64.3% versus 41.5% in the BV+R2 and Pbo+R2 arms, respectively.
FDA Approval Brentuximab Vedotin Lenalidomide Rituximab LBCL Relapsed Or Refractory Lymphoma Stem Cell Transplant CAR T-Cell Therapy
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