- The FDA has approved brentuximab vedotin (BV) injection in combination with chemotherapy for adult patients with anaplastic large cell lymphoma (ALCL) and other CD30-expressing peripheral T-cell lymphomas (PTCLs).
- This is the first FDA-approved first-line treatment for PTCL.
Why this matters
- Approval was granted via the Real-Time Oncology Review (RTOR) program, a new system that allows the FDA’s review team to access and begin reviewing key data before actual submission.
- Phase 3 ECHELON-2 trial of 452 patients with CD30-expressing PTCL receiving first-line CHOP alone (cyclophosphamide, doxorubicin, vincristine, and prednisone), or BV+CHP.
- Funding: Seattle Genetics.
- BV+CHP reduced the risk for death by 34% vs CHOP: HR, 0.66; 95% CI, 0.46-0.95; P=.024.
- Median PFS: 55.7 (95% CI, 48.2-not estimable [NE]) months with BV+CHP vs 54.2 (95% CI, 13.4-NE) months with CHOP (P=.003).
- 83% (95% CI, 78-88) objective response rate (ORR) with BV+CHP vs 72% (95% CI, 66-78) with CHOP (P=.003).
- 68% (95% CI, 61%-74%) complete remission with BV+CHP vs 56% (95% CI, 49%-62%) with CHOP (P=.007).
- Most common adverse effects with BV+CHP included nausea, diarrhea, fatigue or asthenia, mucositis, and pyrexia.