Ipilimumab & Melanoma (cutaneous)

Approval status

FDA approved on 25 March 2011 for unresectable or metastatic Melanoma (cutaneous), approved on 28 October 2015 for adjuvant treatment in cutaneous melanoma with pathologic regional lymph node involvement >1 mm after complete resection, including total lymphadenectomy.

EMA approved for advanced (unresectable or metastatic) Melanoma (cutaneous) in adults, since 2017, also approved for adolescents aged 12 (5)

Clinical data

Phase III studies with ipilimumab have demonstrated survival benefit in both previously treated and treatment-naïve patients with metastatic Melanoma (cutaneous) (1).

Ipilimumab, an Anti-CTLA-4 / CTLA-4 antibodies, demonstrated improved overall survival (OS) (2, 3).

Ipilimumab elicited a dose-dependent effect on efficacy and safety measures in pretreated patients with advanced melanoma, lending support to further studies at a dose of 10 mg/kg (4)

References

(1) Lacouture et al., 2014
(2) Hodi et al., 2010
(3) Robert et al. 2011 N Engl J Med 364(26): 2517-2526
(4) Wolchok et al., 2010a
(5) Amaral et al. 2025 Ann Oncol 36(1): 10-30

see also:
Anti-CTLA-4 / CTLA-4 antibodies & Melanoma (cutaneous)
Melanoma (cutaneous) & Drugs/Treatments