# Gastrointestinal stromal tumour

The EU has approved 6 indications of 5 drugs in gastrointestinal stromal tumour. 3 of them need a biomarker result: KIT (2) and PDGFR (1). 6 tumour-agnostic approvals also apply when the tumour carries the alteration.

## Approved indications

### KIT

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Imatinib](https://oncolabels.com/drugs/imatinib) (Glivec) | KIT-positive | Monotherapy | Adjuvant | After resection of Kit (CD117)-positive GIST; Significant risk of relapse; patients who have a low or very low risk of recurrence should not receive adjuvant treatment |
| [Imatinib](https://oncolabels.com/drugs/imatinib) (Glivec) | KIT-positive | Monotherapy | Advanced | - |

### PDGFRA mutation

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Avapritinib](https://oncolabels.com/drugs/avapritinib) (Ayvakyt) | PDGFRA D842V | Monotherapy | Advanced | - |

### No biomarker required

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Sunitinib](https://oncolabels.com/drugs/sunitinib) (Sutent) | None | Monotherapy | 2nd line, advanced | After imatinib treatment (failure due to resistance or intolerance) |
| [Regorafenib](https://oncolabels.com/drugs/regorafenib) (Stivarga) | None | Monotherapy | 3rd line+, advanced | Progressed on or are intolerant to prior treatment with imatinib and sunitinib |
| [Ripretinib](https://oncolabels.com/drugs/ripretinib) (Qinlock) | None | Monotherapy | 3rd line+, advanced | After three or more prior kinase inhibitors, including imatinib |

## Tumour-agnostic approvals

Approved for any solid tumour that carries the alteration, wherever the tumour started.

### EpCAM

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Catumaxomab](https://oncolabels.com/drugs/catumaxomab) (Korjuny) | EpCAM-positive | Monotherapy | 2nd line | Malignant ascites; not eligible for further systemic anticancer therapy Ambiguous in the label (tumour site, line of therapy): check the SmPC. |

### HER2

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Trastuzumab deruxtecan](https://oncolabels.com/drugs/trastuzumab-deruxtecan) (Enhertu) | HER2-positive (IHC 3+) | Monotherapy | 2nd line, advanced | After prior treatment; No satisfactory treatment options |

### NTRK fusion

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Entrectinib](https://oncolabels.com/drugs/entrectinib) (Rozlytrek) | NTRK fusion | Monotherapy | Any line | No prior NTRK inhibitor; Older than 1 month; disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity; no satisfactory treatment options |
| [Larotrectinib](https://oncolabels.com/drugs/larotrectinib) (Vitrakvi) | NTRK fusion | Monotherapy | Any line | Locally advanced, metastatic or where surgical resection is likely to result in severe morbidity; no satisfactory treatment options |
| [Repotrectinib](https://oncolabels.com/drugs/repotrectinib) (Augtyro) | NTRK fusion | Monotherapy | Advanced | Prior NTRK inhibitor, or no prior NTRK inhibitor and treatment options not targeting NTRK provide limited clinical benefit or have been exhausted; Aged 12 years and older |

### RET fusion

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Selpercatinib](https://oncolabels.com/drugs/selpercatinib) (Retsevmo) | RET fusion | Monotherapy | Advanced | Treatment options not targeting RET provide limited clinical benefit, or have been exhausted; Aged 2 years and older |

## Label wording

- **Avapritinib** (Ayvakyt), Gastrointestinal stromal tumour, advanced: “AYVAKYT is indicated as monotherapy for the treatment of adult patients with unresectable or metastatic gastrointestinal stromal tumours (GIST) harbouring the platelet-derived growth factor receptor alpha (PDGFRA) D842V mutation.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/ayvakyt-epar-product-information_en.pdf)
- **Imatinib** (Glivec), Gastrointestinal stromal tumour, advanced: “the treatment of adult patients with Kit (CD 117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (GIST).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/glivec-epar-product-information_en.pdf)
- **Imatinib** (Glivec), Gastrointestinal stromal tumour, adjuvant: “the adjuvant treatment of adult patients who are at significant risk of relapse following resection of Kit (CD117)-positive GIST. Patients who have a low or very low risk of recurrence should not receive adjuvant treatment.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/glivec-epar-product-information_en.pdf)
- **Sunitinib** (Sutent), Gastrointestinal stromal tumour, 2nd line, advanced: “Sutent is indicated for the treatment of unresectable and/or metastatic malignant gastrointestinal stromal tumour (GIST) in adults after failure of imatinib treatment due to resistance or intolerance.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/sutent-epar-product-information_en.pdf)
- **Ripretinib** (Qinlock), Gastrointestinal stromal tumour, 3rd line+, advanced: “QINLOCK is indicated for the treatment of adult patients with advanced gastrointestinal stromal tumour (GIST) who have received prior treatment with three or more kinase inhibitors, including imatinib.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/qinlock-epar-product-information_en.pdf)
- **Regorafenib** (Stivarga), Gastrointestinal stromal tumour, 3rd line+, advanced: “- unresectable or metastatic gastrointestinal stromal tumours (GIST) who progressed on or are intolerant to prior treatment with imatinib and sunitinib” [SmPC](https://www.ema.europa.eu/en/documents/product-information/stivarga-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/tumours/gastrointestinal-stromal-tumour