Full Efficacy & Safety Summary Table
Indication | Patients with relapsed FL following at least 3 prior lines of therapy |
Registrational Trial | Accelerated Approval. Phase 2 single arm ULTRA-V trial (n=117) (NCT03801525) |
Regimen | 800 mg orally once daily with food |
Efficacy Outcomes | ORR: 43% / 3.4% CR DOR: 11.1 mo |
Safety Outcomes | Grade 3/4 AEs: Neutropenia 18%, Diarrhea Colitis: 9%, ALT/AST 9%, Pneumonia 3%, Sepsis 2%, UTI 2% N=221 patients pooled across trials |