Otsuka Holdings Co., Ltd. — Lytgobi EMA EPAR public assessment report (EMEA/H/C/005627, 2023)
Otsuka Holdings Co., Ltd. · 2023 · EMA EPAR public assessment report · company profile →
Report summary
Lytgobi (futibatinib) received a conditional marketing authorization recommendation for advanced cholangiocarcinoma with FGFR2 fusions/rearrangements in adults who progressed after prior systemic therapy. This was based on a single-arm Phase 2 study (TAS-120-101) showing a 41.7% objective response rate and 9.7 months median duration of response, addressing a significant unmet medical need. While effective, futibatinib exhibits a high incidence of adverse events, particularly hyperphosphatemia, and other toxicities like retinal disorders and hepatotoxicity, requiring dose modifications. Non-clinical studies revealed dose-dependent toxicities including ectopic mineralization and teratogenicity. Despite concerns regarding the single-arm trial's robustness, the CHMP concluded a positive benefit-risk balance.
Key findings — cited to the page
| patients with nausea (any grade, SDG1) | 41 | · p.87 |
| patients with fatigue (any grade, SDG1) | 45 | · p.87 |
| patients with alopecia (any grade, SDG1) | 51 | · p.87 |
| patients with constipation (any grade, SDG1) | 54 | · p.87 |
| patients with diarrhea (any grade, SDG1) | 49 | · p.87 |
| patients with dry mouth (any grade, SDG1) | 45 | · p.87 |
| patients with treatment-related Grade >=3 AEs (SDG1) | 79 | · p.85 |
| patients with Grade >=3 AEs (SDG1) | 111 | · p.85 |
| patients with hyperphosphatemia (any grade, SDG1) | 124 | · p.87 |
| patients with Grade >=3 hyperphosphatemia (SDG1) | 39 | · p.87 |
| Grade ≥3 TREAEs: Stomatitis | 6.2 % | Lytgobi (SDG1) · p.112 |
| patients with dry skin (any grade, SDG1) | 40 | · p.87 |
Source: Otsuka Holdings Co., Ltd. ↗ · 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 →