Neuroendocrine tumours
The EU has approved 6 indications of 5 drugs in neuroendocrine tumours. 1 of them needs a biomarker result: Somatostatin receptor (1). 6 tumour-agnostic approvals also apply when the tumour carries the alteration.
Site
Disease setting
| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| Somatostatin receptor-positive1 | ||||
Lutathera | Monotherapy | Any line advanced | Gastroenteropancreatic NET only; Progressive; well-differentiated (G1 and G2) | |
| No biomarker required5 | ||||
Cabometyx | None | Monotherapy | 2L advanced | Progressed following at least one prior systemic therapy other than somatostatin analogues |
Weliregconditional | None | Monotherapy | Any line early | Pancreatic NET only; Von Hippel-Lindau disease; localised procedures are unsuitable |
Afinitor | None | Monotherapy | Any line advanced | Pancreatic NET only; Well- or moderately-differentiated; progressive disease |
Afinitor | None | Monotherapy | Any line advanced | Gastrointestinal or lung NET only; Well-differentiated (Grade 1 or Grade 2); non-functional; progressive disease |
Sutent | None | Monotherapy | Any line advanced | Well-differentiated pancreatic NET only; Disease progression |
Tumour-agnostic approvals6
Approved for any solid tumour that carries the alteration, wherever the tumour started.
| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| EpCAM1 | ||||
Korjuny | Monotherapy | 2L | Malignant ascites; not eligible for further systemic anticancer therapy | |
| HER21 | ||||
Enhertuconditional | HER2-positive (IHC 3+) | Monotherapy | 2L advanced | After prior treatment; No satisfactory treatment options |
| NTRK fusion3 | ||||
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 | |
Vitrakviconditional | Monotherapy | Any line | Locally advanced, metastatic or where surgical resection is likely to result in severe morbidity; no satisfactory treatment options | |
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 | ||||
Retsevmo | Monotherapy | Any line advanced | Treatment options not targeting RET provide limited clinical benefit, or have been exhausted; Aged 2 years and older | |
Biomarkers in neuroendocrine tumours
Label wording6
The sentence from section 4.1 of the SmPC that each indication above comes from.
- Everolimus (Afinitor)
Afinitor is indicated for the treatment of unresectable or metastatic, well- or moderately-differentiated neuroendocrine tumours of pancreatic origin in adults with progressive disease.
- Everolimus (Afinitor)
Afinitor is indicated for the treatment of unresectable or metastatic, well-differentiated (Grade 1 or Grade 2) non-functional neuroendocrine tumours of gastrointestinal or lung origin in adults with progressive disease (see sections 4.4 and 5.1).
- Cabozantinib (Cabometyx)
CABOMETYX is indicated for the treatment of adult patients with unresectable or metastatic, well differentiated extra-pancreatic (epNET) and pancreatic (pNET) neuroendocrine tumours who have progressed following at least one prior systemic therapy other than somatostatin analogues.
- Belzutifan (Welireg)
WELIREG is indicated as monotherapy for the treatment of adult patients with von Hippel-Lindau disease who require therapy for associated, localised renal cell carcinoma (RCC), central nervous system (CNS) haemangioblastomas, or pancreatic neuroendocrine tumours (pNET), and for whom localised procedures are unsuitable.
- Sunitinib (Sutent)
Sutent is indicated for the treatment of unresectable or metastatic, well-differentiated pancreatic neuroendocrine tumours (pNET) with disease progression in adults.
- Lutetium (177Lu) oxodotreotide (Lutathera)
Lutathera is indicated for the treatment of unresectable or metastatic, progressive, well-differentiated (G1 and G2), somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumours (GEP-NETs) in adults.