SEATTLE GENETICS — Adcetris FDA Review (NDA/BLA 125388, 2026)
Pfizer Inc. · 2026 · FDA Review (Drugs@FDA) · company profile →
Report summary
The FDA approved Adcetris (brentuximab vedotin) in combination with lenalidomide and rituximab for adult patients with relapsed or refractory large B-cell lymphoma (LBCL) ineligible for auto-HSCT or CAR T-cell therapy, effective February 11, 2025. This approval, based on the ECHELON-3 trial, demonstrated significant improvements in overall survival (OS) and progression-free survival (PFS) compared to placebo. The report details Adcetris's clinical pharmacology, efficacy across various lymphoma types, and safety profile, including peripheral neuropathy and hematologic toxicities. While efficacy-exposure relationships were unclear, higher exposure correlated with increased adverse events, leading to FDA recommendations for dose adjustments in patients with hepatic impairment. The review also covers manufacturing, labeling, and financial disclosures.
Key findings — cited to the page
| Frequency of restart dosage for Grade 3 peripheral neuropathy (1.2 mg/kg every 2 weeks regimen) | every 2 weeks | ADCETRIS · p.14 |
| Maximum restart dosage for Grade 3 sensory neuropathy (1.2 mg/kg every 3 weeks regimen) | 90 mg | ADCETRIS · p.14 |
| Maximum dose reduction for Grade 2 peripheral neuropathy (1.2 mg/kg every 2 weeks regimen) | 90 mg | ADCETRIS · p.14 |
| Maximum restart dosage for Grade 3 peripheral neuropathy (1.2 mg/kg every 2 weeks regimen) | 90 mg | ADCETRIS · p.14 |
| Maximum dose reduction for Grade 2 motor neuropathy (1.2 mg/kg every 3 weeks regimen) | 90 mg | ADCETRIS · p.14 |
| Frequency of dose reduction for Grade 2 motor neuropathy (1.2 mg/kg every 3 weeks regimen) | every 3 weeks | ADCETRIS · p.14 |
| Restart dosage for Grade 3 sensory neuropathy (1.2 mg/kg every 3 weeks regimen) | 0.9 mg/kg | ADCETRIS · p.14 |
| Dose reduction for Grade 2 peripheral neuropathy (1.2 mg/kg every 2 weeks regimen) | 0.9 mg/kg | ADCETRIS · p.14 |
| Frequency of dose reduction for Grade 2 peripheral neuropathy (1.2 mg/kg every 2 weeks regimen) | every 2 weeks | ADCETRIS · p.14 |
| Restart dosage for Grade 3 peripheral neuropathy (1.2 mg/kg every 2 weeks regimen) | 0.9 mg/kg | ADCETRIS · p.14 |
| Dose reduction for Grade 2 motor neuropathy (1.2 mg/kg every 3 weeks regimen) | 0.9 mg/kg | ADCETRIS · p.14 |
| Frequency of restart dosage for Grade 3 sensory neuropathy (1.2 mg/kg every 3 weeks regimen) | every 3 weeks | ADCETRIS · p.14 |
Source: Pfizer Inc. ↗ · License: US Government public domain. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Oncology library →