Lytgobi futibatinib
Oncology· 762 cited findings· 1 source document
Company: Otsuka Holdings Co., Ltd.
What the regulatory reviews say
Lytgobi (futibatinib) is indicated for the treatment of locally advanced or metastatic intrahepatic cholangiocarcinoma (CCA) with FGFR2 gene rearrangements, including fusions, in adult patients who have previously received at least one prior systemic therapy. CCA has an incidence of 1 to 3 patients per 100,000.
In a confirmatory Phase 2 study involving 120 patients, Lytgobi demonstrated an objective response rate (ORR) of 37.3% (95% CI: 25.8, 50.0) in an interim analysis. The median duration of response (DOR) for responders was 9.69 months (95% CI: 7.62, 17.05), with 72.1% of responders having a DOR of at least 6 months. The median progression-free survival (PFS) was 9.0 months (95% CI: 6.9, 13.1), and the median overall survival (OS) was 21.7 months (95% CI: 14.5, NE). The starting dose for Lytgobi is 20 mg once daily.
Safety findings include 5 patients discontinuing due to Adverse Events/SAEs. No patients experienced treatment-related AEs leading to death. The CHMP issued a positive opinion for Lytgobi on 26 April 2023. The drug received orphan medicinal product designation on 01 April 2019, which was withdrawn on 16 May 2023.
Key figures — cited to the source page
| ORR (interim analysis) | 37.3 % | Otsuka Holdings Co., Ltd. — Lytgobi EMA EPAR public assessme, p.68 |
| median DOR (responders) | 9.69 months | Otsuka Holdings Co., Ltd. — Lytgobi EMA EPAR public assessme, p.68 |
| median PFS | 9.0 months | Otsuka Holdings Co., Ltd. — Lytgobi EMA EPAR public assessme, p.70 |
| median OS | 21.7 months | Otsuka Holdings Co., Ltd. — Lytgobi EMA EPAR public assessme, p.70 |
| discontinuation due to Adverse Event/SAE | 5 | Otsuka Holdings Co., Ltd. — Lytgobi EMA EPAR public assessme, p.64 |
| patients with treatment-related AEs leading to death | 0 | Otsuka Holdings Co., Ltd. — Lytgobi EMA EPAR public assessme, p.85 |
| Orphan medicinal product designation date | 01 April 2019 | Otsuka Holdings Co., Ltd. — Lytgobi EMA EPAR public assessme, p.7 |
| CHMP positive opinion date | 26 April 2023 | Otsuka Holdings Co., Ltd. — Lytgobi EMA EPAR public assessme, p.9 |
Source documents
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Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.