Gilead Sciences, Inc. — Tecartus EMA EPAR variation assessment report (EMEA/H/C/005102, 2020)
Gilead Sciences, Inc. · 2020 · EMA EPAR variation assessment report · company profile →
Report summary
This report details a Type II variation for Tecartus (brexucabtagene autoleucel) to extend its indication to adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia (B-ALL). The application includes a dose specification change. Pharmacokinetic and pharmacodynamic analyses from the ZUMA-3 trial show CAR T-cell levels and their association with clinical outcomes. The ZUMA-3 Phase 2 study, a single-arm, open-label trial, demonstrated an overall complete remission rate (OCR) of 70.9% and a median overall survival of 18.2 months. Efficacy and safety data, including adverse events like CRS (89%) and neurologic events (60%), are presented, highlighting Tecartus's benefit over standard care. Safety concerns, risk minimization, and pharmacovigilance activities are discussed. The report concludes that the benefit-risk balance for Tecartus in this new indication is positive, leading to conditional marketing authorization.
Key findings — cited to the page
| Worst Grade ≥ 3 TE neurologic event (1 Prior Therapy) | 3 | ZUMA-3 (Phase 2, Safety Analysis Set) · p.67 |
| Worst Grade ≥ 3 serious KTE-X19 related TEAE (1 Prior Therapy) | 5 | ZUMA-3 (Phase 2, Safety Analysis Set) · p.67 |
| Worst Grade ≥ 3 TE CRS (1 Prior Therapy) | 1 | ZUMA-3 (Phase 2, Safety Analysis Set) · p.67 |
| Worst Grade ≥ 3 TE CRS (>1 Prior Therapy) | 12 | ZUMA-3 (Phase 2, Safety Analysis Set) · p.67 |
| Worst Grade ≥ 3 KTE-X19 related TEAE (1 Prior Therapy) | 9 | ZUMA-3 (Phase 2, Safety Analysis Set) · p.67 |
| Worst Grade ≥ 3 KTE-X19 related TEAE (>1 Prior Therapy) | 40 | ZUMA-3 (Phase 2, Safety Analysis Set) · p.67 |
| Worst Grade ≥ 3 serious TEAE (1 Prior Therapy) | 6 | ZUMA-3 (Phase 2, Safety Analysis Set) · p.67 |
| Worst Grade ≥ 3 serious KTE-X19 related TEAE (>1 Prior Therapy) | 26 | ZUMA-3 (Phase 2, Safety Analysis Set) · p.67 |
| Worst Grade ≥ 3 TEAE (>1 Prior Therapy) | 43 | ZUMA-3 (Phase 2, Safety Analysis Set) · p.67 |
| Worst Grade ≥ 3 TEAE (1 Prior Therapy) | 9 | ZUMA-3 (Phase 2, Safety Analysis Set) · p.67 |
| Worst Grade ≥ 3 serious TEAE (>1 Prior Therapy) | 34 | ZUMA-3 (Phase 2, Safety Analysis Set) · p.67 |
| Worst Grade ≥ 3 TE neurologic event (>1 Prior Therapy) | 11 | ZUMA-3 (Phase 2, Safety Analysis Set) · p.67 |
Source: Gilead Sciences, Inc. ↗ · License: EMA - reuse permitted with acknowledgement. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Oncology library →