Uveal melanoma

The EU has approved 7 indications of 5 drugs in uveal melanoma. 2 of them need a biomarker result: HLA-A*02:01 (1) and PD-L1 (1). 6 tumour-agnostic approvals also apply when the tumour carries the alteration.

Approved indications, Uveal melanoma
Drug	Biomarker requirement	Regimen	Setting	Conditions

HLA-A*02:01-positive1
Tebentafusp Kimmtrak		Monotherapy	Any line advanced	None

PD-L11
Relatlimab + nivolumab Opdualag	TPS < 1%	Monotherapy	1L advanced	Melanoma label; uveal melanoma was excluded from the trials; Aged 12 years and older

No biomarker required5
Ipilimumab Yervoy	None	+ nivolumab	Any line advanced	Melanoma label; uveal melanoma was excluded from the trials
Ipilimumab Yervoy	None	Monotherapy	Any line advanced	Melanoma label; uveal melanoma was excluded from the trials
Nivolumab Opdivo	None	+ ipilimumab	Any line advanced	Melanoma label; uveal melanoma was excluded from the trials
Nivolumab Opdivo	None	Monotherapy	Any line advanced	Melanoma label; uveal melanoma was excluded from the trials
Pembrolizumab Keytruda	None	Monotherapy	Any line advanced	Melanoma label; uveal melanoma was excluded from the trials

Tumour-agnostic approvals6

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

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

Biomarkers in uveal melanoma

Label wording7

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

Pembrolizumab (Keytruda)
KEYTRUDA as monotherapy is indicated for the treatment of adults and adolescents aged 12 years and older with advanced (unresectable or metastatic) melanoma.
Nivolumab (Opdivo)
OPDIVO as monotherapy or in combination with ipilimumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older.
Nivolumab (Opdivo)
OPDIVO as monotherapy or in combination with ipilimumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older.
Relatlimab + nivolumab (Opdualag)
Opdualag is indicated for the first-line treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older with tumour cell PD-L1 expression < 1%.
Ipilimumab (Yervoy)
YERVOY as monotherapy or in combination with nivolumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older (see section 4.4).
Ipilimumab (Yervoy)
YERVOY as monotherapy or in combination with nivolumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older (see section 4.4).
Tebentafusp (Kimmtrak)
KIMMTRAK is indicated as monotherapy for the treatment of human leukocyte antigen (HLA)-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma.