# Fedratinib

Fedratinib (Inrebic, Bristol Myers Squibb Pharma EEIG) has 1 EU-approved indication in 1 tumour type.

## Approved indications

### Myeloproliferative neoplasms

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | Monotherapy | Any line | Myelofibrosis only; Janus Associated Kinase (JAK) inhibitor naïve or treated with ruxolitinib; Disease-related splenomegaly or symptoms |

## Products

### Inrebic

- Company: Bristol Myers Squibb Pharma EEIG
- Target: JAK2 inhibitor
- Class: Janus-associated kinase (JAK) inhibitors
- ATC: L01EJ02
- EU approval: 8 Feb 2021
- Label revised: 19 Aug 2026
- Status: orphan medicine
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/inrebic-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/inrebic-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/inrebic

Mechanism (SmPC section 5.1): Fedratinib selectively inhibits JAK2 and FLT3, reducing JAK2-mediated phosphorylation of STAT3 and STAT5 proteins and inhibiting malignant cell proliferation.

## Label wording

- **Fedratinib** (Inrebic), Myeloproliferative neoplasms, any line: “Inrebic is indicated for the treatment of disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis, post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis who are Janus Associated Kinase (JAK) inhibitor naïve or have been treated with ruxolitinib.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/inrebic-epar-product-information_en.pdf)

Source: section 4.1 of each summary of product characteristics (SmPC), EMA data as of 5 Nov 2026. AI models structured these entries and no person has checked them yet. oncolabels is a non-commercial reference for education and research and gives no medical advice; the current SmPC takes precedence.

Data under CC BY 4.0: credit oncolabels and the European Medicines Agency. Page: https://oncolabels.com/drugs/fedratinib