What changed: Melanoma

When this page itself was last checked or edited.

Accelerated approval of vusolimogene oderparepvec in combination with nivolumab, unresectable advanced cutaneous melanoma

Accelerated approval with nivolumab for unresectable/metastatic melanoma after anti-PD-1 (IGNYTE) The confirmatory requirement was still open 0.1 years later, when the FDA's table was read.

CHMP negative opinion on Tacquell (autologous TIL) for melanoma; applicant Netherlands Cancer Institute

Unresectable/metastatic melanoma after anti-PD-1, with nivolumab (accelerated)

First-line metastatic phase 3 missed its primary PFS endpoint (Regeneron release)

Primary PFS endpoint not met; numerical +5.

RFS and DMFS significantly improved (HRs pending presentation).

A milestone in how this cancer is treated.

A milestone in how this cancer is treated.

RFS not improved.

A milestone in how this cancer is treated.

Accelerated approval, unresectable/metastatic melanoma after anti-PD-1 (C-144-01): first TIL therapy The confirmatory requirement was still open 2.6 years later, when the FDA's table was read.

Unresectable/metastatic melanoma after anti-PD-1 (and BRAF/MEK if applicable)

Advanced NRAS-mutant melanoma after prior immunotherapy

12-month EFS 83.

A milestone in how this cancer is treated.

A milestone in how this cancer is treated.

Breakthrough Therapy designation, anti-PD-1-failed melanoma

Breakthrough Therapy designation, adjuvant melanoma

ORR 65% (13 of 20), 4 complete responses; no FMT-related serious adverse events.

EMA approval, PD-L1 <1% melanoma

EMA approval

Unresectable or metastatic melanoma, age ≥12 (RELATIVITY-047): first LAG-3 therapy

HLA-A*02:01+ unresectable or metastatic uveal melanoma: first TCR therapeutic approved

Previously treated MSI-high or dMMR advanced solid tumours; unresectable or metastatic melanoma after prior therapy

Melanoma, PD-L1 <1% restriction

Unresectable or metastatic melanoma, age ≥12

HLA-A*02:01+ metastatic uveal melanoma

Nivolumab plus low-dose ipilimumab did not improve recurrence-free survival over nivolumab alone after resection of stage III to IV melanoma.

PFS HR 0.

2-year EFS 72% vs 49%; HR 0.

A milestone in how this cancer is treated.

Breakthrough Therapy designation

ORR 31.

2-year OS 71.

6 of 15 patients with clinical benefit (3 objective responses).

OS 21.

RFS and DMFS improved; 5-year benefit sustained (ESMO 2025).

A milestone in how this cancer is treated.

With atezolizumab and vemurafenib in BRAF V600 melanoma

Atezolizumab added to vemurafenib and cobimetinib prolonged investigator-assessed progression-free survival in BRAF V600-mutant melanoma, without an overall survival benefit; approved in July 2020.

Encorafenib + binimetinib approved for BRAF V600 melanoma

BRAF V600 melanoma with binimetinib (COLUMBUS)

BRAF V600E/K melanoma with encorafenib

BRAF V600E-mutant metastatic colorectal cancer, with cetuximab

BRAF V600 melanoma with binimetinib

Intracranial clinical benefit 57% and complete response 26% in the asymptomatic cohort.

PFS 14.

A milestone in how this cancer is treated.

12-month recurrence-free survival 70.

10-year RFS 48% vs 32%; DMFS 63% vs 48%.

No melanoma-specific survival benefit; lymphoedema 24% vs 6%.

A milestone in how this cancer is treated.

Adjuvant stage III melanoma (10 mg/kg; later superseded)

Unresectable melanoma with injectable lesions (OPTiM): first oncolytic virus approved in the US

With ipilimumab, BRAF wild-type melanoma (CheckMate 067)

BRAF V600 melanoma with vemurafenib

Unresectable melanoma with injectable lesions

10-year OS 43% vs 37% vs 19%.

10-year OS 34.

A milestone in how this cancer is treated.

A milestone in how this cancer is treated.

Advanced melanoma after ipilimumab (accelerated)

Accelerated approval, advanced melanoma after ipilimumab; first PD-1 inhibitor in the US

First PD-1 inhibitor approved worldwide (melanoma, Japan)

BRAF V600E/K unresectable or metastatic melanoma, combination (accelerated; each drug alone approved 2013)

With trametinib: BRAF V600E/K metastatic melanoma; later adjuvant melanoma, BRAF V600E NSCLC, anaplastic thyroid cancer, tumour-agnostic solid tumours and paediatric low-grade glioma

Melanoma

Melanoma (first of >40 indications)

Sentinel node imaging in breast cancer, melanoma, oral SCC

BRAF V600 melanoma alone or with dabrafenib; later NSCLC and adjuvant melanoma

With dabrafenib: metastatic melanoma; later adjuvant melanoma, NSCLC, anaplastic thyroid cancer, tumour-agnostic BRAF V600E solid tumours, paediatric low-grade glioma

Median progression-free survival 12.

Median progression-free survival 11.

A milestone in how this cancer is treated.

A milestone in how this cancer is treated.

BRAF V600 melanoma; later NSCLC and adjuvant melanoma with trametinib

BRAF V600E unresectable or metastatic melanoma (single agent)

Lymphatic mapping with a handheld gamma counter in breast cancer and melanoma

BRAF V600E/K unresectable or metastatic melanoma (single agent)

No difference in the appropriateness of referral (56.

Approved with the cobas BRAF V600 companion test, the first melanoma targeted therapy

Metastatic melanoma: first checkpoint inhibitor approved anywhere

Metastatic melanoma

Adjuvant treatment of melanoma with nodal involvement after complete resection (Sylatron)

Unresectable or metastatic BRAF V600E melanoma

A milestone in how this cancer is treated.

Immunotherapy and targeted therapy arrive in the same year.

Hodi et al., NEJM.

Davies et al., Nature.

Metastatic melanoma

Adjuvant high-risk melanoma (high-dose)

The first evidence that the immune system alone could eradicate metastatic melanoma.

Metastatic malignant melanoma; Hodgkin disease (second line, combination)

A milestone in how this cancer is treated.