Solid tumours, tumour-agnostic

The EU has approved 6 indications of 6 drugs in solid tumours, tumour-agnostic. Each needs a biomarker result: NTRK (3), EpCAM (1), HER2 (1) and RET (1).

Approved indications, Solid tumours, tumour-agnostic
Drug	Biomarker requirement	Regimen	Setting	Conditions

EpCAM1
Catumaxomab Korjuny		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
Selpercatinib Retsevmo		Monotherapy	Any line advanced	Treatment options not targeting RET provide limited clinical benefit, or have been exhausted; Aged 2 years and older

Label wording6

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

Entrectinib (Rozlytrek)
Rozlytrek as monotherapy is indicated for the treatment of adult and paediatric patients older than 1 month with solid tumours that have a NTRK gene fusion,  who have a disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, and  who have not received a prior NTRK inhibitor  who have no satisfactory treatment options (see sections 4.4 and 5.1).
Trastuzumab deruxtecan (Enhertu)
Enhertu as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC3+) solid tumours who have received prior treatment and who have no satisfactory treatment options (see sections 4.4 and 5.1; for biomarker-based patient selection, see section 4.2).
Larotrectinib (Vitrakvi)
VITRAKVI as monotherapy is indicated for the treatment of adult and paediatric patients with solid tumours that display a Neurotrophic Tyrosine Receptor Kinase (NTRK) gene fusion, - who have a disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, and - who have no satisfactory treatment options (see sections 4.4 and 5.1).
Selpercatinib (Retsevmo)
advanced RET fusion-positive solid tumours, when treatment options not targeting RET provide limited clinical benefit, or have been exhausted (see sections 4.4 and 5.1).
Catumaxomab (Korjuny)
Korjuny is indicated for the intraperitoneal treatment of malignant ascites in adults with epithelial cellular adhesion molecule (EpCAM)-positive carcinomas, who are not eligible for further systemic anticancer therapy.
Repotrectinib (Augtyro)
AUGTYRO as monotherapy is indicated for the treatment of adult and paediatric patients 12 years of age and older with advanced solid tumours expressing a NTRK gene fusion, and  who have received a prior NTRK inhibitor, or  have not received a prior NTRK inhibitor and treatment options not targeting NTRK provide limited clinical benefit, or have been exhausted (see sections 4.4 and 5.1)