What changed: Advanced melanoma (unresectable stage III and stage IV)

When this page itself was last checked or edited.

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.

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

Primary PFS endpoint not met; numerical +5.

A milestone in how this cancer is treated.

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)

A milestone in how this cancer is treated.

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

Unresectable or metastatic melanoma, age ≥12

PFS HR 0.

A milestone in how this cancer is treated.

ORR 31.

2-year OS 71.

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

PFS 14.

A milestone in how this cancer is treated.

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

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.

Advanced melanoma after ipilimumab (accelerated)

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

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

Median progression-free survival 12.

Median progression-free survival 11.

A milestone in how this cancer is treated.

Metastatic melanoma: first checkpoint inhibitor approved anywhere

Metastatic melanoma

A milestone in how this cancer is treated.

Metastatic melanoma

A milestone in how this cancer is treated.

A milestone in how this cancer is treated.