Pfizer’s Adcetris Receives FDA Approval For Treating Large B-Cell Lymphoma

Pfizer’s Adcetris (brentuximab vedotin) has secured a new FDA approval to treat patients with large B-cell lymphoma (LBCL), marking another milestone for the blood cancer drug. More than 13 years after its initial approval, Adcetris is now authorized for use in combination with lenalidomide and rituximab for certain LBCL patients who have undergone at least two prior lines of systemic therapy and are ineligible for autologous stem cell transplant or CAR-T therapy.

The approval comes after positive results from the phase 3 ECHELON-3 study, which demonstrated that the triplet combination of Adcetris, lenalidomide, and rituximab significantly improved survival outcomes for heavily pretreated LBCL patients. Specifically, the treatment regimen reduced the risk of death by 37.1% and extended patients’ median survival time by 5.3 months, from 8.5 months to 13.8 months.

Additionally, the combination reduced the risk of disease progression or death by 47.3%, highlighting its effectiveness in this challenging patient population. The findings were presented at the American Society of Clinical Oncology (ASCO) annual meeting in 2024.

This new approval further establishes Adcetris as a valuable option for patients with advanced, difficult-to-treat forms of lymphoma, offering hope for longer survival and improved quality of life.

News Source