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.

Disease setting

Approved indications, Gastrointestinal stromal tumour
DrugBiomarker requirementRegimenSettingConditions
KIT2
Imatinib
Glivec
Monotherapy
Adj.
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
Glivec
Monotherapy
Any line
advanced
None
PDGFRA mutation1
Avapritinib
Ayvakytconditional
D842V
Monotherapy
Any line
advanced
None
No biomarker required3
Sunitinib
Sutent
None
Monotherapy
2L
advanced
After imatinib treatment (failure due to resistance or intolerance)
Regorafenib
Stivarga
None
Monotherapy
3L+
advanced
Progressed on or are intolerant to prior treatment with imatinib and sunitinib
Ripretinib
Qinlock
None
Monotherapy
3L+
advanced
After three or more prior kinase inhibitors, including imatinib

Tumour-agnostic approvals6

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

DrugBiomarker requirementRegimenSettingConditions
EpCAM1
Monotherapy
2L
Malignant ascites; not eligible for further systemic anticancer therapy
HER21
Trastuzumab deruxtecan
Enhertuconditional
HER2-positive (IHC 3+)
Monotherapy
2L
advanced
After prior treatment; No satisfactory treatment options
NTRK fusion3
Entrectinib
Rozlytrekconditional
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
Vitrakviconditional
Monotherapy
Any line
Locally advanced, metastatic or where surgical resection is likely to result in severe morbidity; no satisfactory treatment options
Repotrectinib
Augtyroconditional
Monotherapy
Any line
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 fusion1
Monotherapy
Any line
advanced
Treatment options not targeting RET provide limited clinical benefit, or have been exhausted; Aged 2 years and older

Biomarkers in gastrointestinal stromal tumour

Label wording6

The sentence from section 4.1 of the SmPC that each indication above comes from.

  1. Avapritinib (Ayvakyt)
    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.
  2. Imatinib (Glivec)
    the treatment of adult patients with Kit (CD 117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (GIST).
  3. Imatinib (Glivec)
    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.
  4. Sunitinib (Sutent)
    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.
  5. Ripretinib (Qinlock)
    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.
  6. Regorafenib (Stivarga)
    - unresectable or metastatic gastrointestinal stromal tumours (GIST) who progressed on or are intolerant to prior treatment with imatinib and sunitinib