Melanoma
The EU has approved 19 indications of 11 drugs in melanoma. 11 of them need a biomarker result: BRAF (10) and PD-L1 (1). 6 tumour-agnostic approvals also apply when the tumour carries the alteration.
Disease setting
| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| BRAF mutation10 | ||||
Tafinlar | V600 | + trametinib | Adj. locally adv. | After complete resection; Aged 12 years and older |
Mekinist | V600 | + dabrafenib | Adj. locally adv. | Following complete resection; Aged 12 years and older |
Mektovi | V600 | + encorafenib | Any line advanced | None |
Cotellic | V600 | + vemurafenib | Any line advanced | None |
Tafinlar | V600 | + trametinib | Any line advanced | Aged 12 years and older |
Tafinlar | V600 | Monotherapy | Any line advanced | Aged 12 years and older |
Braftovi | V600 | + binimetinib | Any line advanced | None |
Mekinist | V600 | + dabrafenib | Any line advanced | Aged 12 years and older |
Mekinist | V600 | Monotherapy | Any line advanced | Aged 12 years and older |
Zelboraf | V600 | Monotherapy | Any line advanced | None |
| PD-L11 | ||||
Opdualag | TPS < 1% | Monotherapy | 1L advanced | Aged 12 years and older |
| No biomarker required8 | ||||
Opdivo | None | Monotherapy | Adj. | After complete resection; Stage IIB or IIC melanoma, or melanoma with involvement of lymph nodes or metastatic disease |
Keytruda | None | Monotherapy | Adj. | After complete resection; Stage IIB, IIC or III |
Yervoy | None | + nivolumab | Any line advanced | None |
Yervoy | None | Monotherapy | Any line advanced | None |
Opdivo | None | + ipilimumab | Any line advanced | None |
Opdivo | None | Monotherapy | Any line advanced | None |
Keytruda | None | Monotherapy | Any line advanced | None |
Imlygic | None | Monotherapy | Any line advanced | Unresectable; Stage IIIB, IIIC and IVM1a; no bone, brain, lung or other visceral disease |
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 melanoma
Label wording19
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.
- Pembrolizumab (Keytruda)
KEYTRUDA as monotherapy is indicated for the adjuvant treatment of adults and adolescents aged 12 years and older with Stage IIB, IIC or III melanoma and who have undergone complete resection (see section 5.1).
- Nivolumab (Opdivo)
OPDIVO as monotherapy is indicated for the adjuvant treatment of adults and adolescents 12 years of age and older with Stage IIB or IIC melanoma, or melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection (see section 5.1).
- 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%.
- Encorafenib (Braftovi)
Encorafenib in combination with binimetinib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation.
- 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).
- Trametinib (Mekinist)
Trametinib as monotherapy or in combination with dabrafenib is indicated for the treatment of adults and adolescents aged 12 years and older with unresectable or metastatic melanoma with a BRAF V600 mutation (see sections 4.4 and 5.1).
- Trametinib (Mekinist)
Trametinib as monotherapy or in combination with dabrafenib is indicated for the treatment of adults and adolescents aged 12 years and older with unresectable or metastatic melanoma with a BRAF V600 mutation (see sections 4.4 and 5.1).
- Trametinib (Mekinist)
Trametinib in combination with dabrafenib is indicated for the adjuvant treatment of adults and adolescents aged 12 years and older with Stage III melanoma with a BRAF V600 mutation, following complete resection.
- Dabrafenib (Tafinlar)
Dabrafenib as monotherapy or in combination with trametinib is indicated for the treatment of adults and adolescents aged 12 years and older with unresectable or metastatic melanoma with a BRAF V600 mutation (see sections 4.4 and 5.1).
- Dabrafenib (Tafinlar)
Dabrafenib as monotherapy or in combination with trametinib is indicated for the treatment of adults and adolescents aged 12 years and older with unresectable or metastatic melanoma with a BRAF V600 mutation (see sections 4.4 and 5.1).
- Dabrafenib (Tafinlar)
Dabrafenib in combination with trametinib is indicated for the adjuvant treatment of adults and adolescents aged 12 years and older with Stage III melanoma with a BRAF V600 mutation, following complete resection.
- Talimogene laherparepvec (Imlygic)
Imlygic is indicated for the treatment of adults with unresectable melanoma that is regionally or distantly metastatic (Stage IIIB, IIIC and IVM1a) with no bone, brain, lung or other visceral disease (see sections 4.4 and 5.1).
- Binimetinib (Mektovi)
Binimetinib in combination with encorafenib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation.
- Cobimetinib (Cotellic)
Cotellic is indicated for use in combination with vemurafenib for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation (see sections 4.4 and 5.1).
- Vemurafenib (Zelboraf)
Vemurafenib is indicated in monotherapy for the treatment of adult patients with BRAF V600 mutation-positive unresectable or metastatic melanoma (see section 5.1).