On 25March 2011, the US Food and Drug Administration (FDA) approved ipilimumab 3 mg/kg for the treatment of patients with unresectable (inoperable) or metastatic melanoma in the US. On 13 July 2011, the EU approved ipilimumab 3 mg/kg for the treatment of adult patients with previously-treated unresectable or metastatic melanoma.
YERVOY, which is a recombinant, human monoclonal antibody, is the first FDA-approved cancer immunotherapy that blocks the cytotoxic T- lymphocyte antigen-4 (CTLA-4). CTLA-4 is a negative regulator of T-cell activation.Ipilimumab binds to CTLA-4 and blocks the interaction of CTLA-4 with its ligands, CD80/CD86. Blockade of CTLA-4 has been shown to augment T-cell activation and proliferation. The mechanism of action of ipilimumab's effect in patients with melanoma is indirect, possibly through T-cell mediated anti-tumor immune responses.
For full Prescribing Information, please refer to the SMPC.
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1. Weber J, Thompson JA, Hamid O, et al. A randomized, double-blind, placebo-controlled, phase II study comparing the tolerability and efficacy of ipilimumab administered with or without prophylactic budesonide in patients with unresectable stage III or IV melanoma. Clin Cancer Res 2009;15:5591-5598.
2. Wolchok JD, Neyns B, Linette G, et al. Ipilimumab monotherapy in patients with pretreated advanced melanoma: a randomised, double-blind, multicentre, phase 2, dose-ranging study. Lancet Oncol 2010;11:155-164.
3. O'Day SJ, Maio M, Chiarion-Sileni V, et al. Efficacy and safety of ipilimumab monotherapy in patients with pretreated advanced melanoma: a multicentre, single-arm, phase II study. Ann Oncol 2010;21:1712-1717.
4. Thomas L, Wolchok JD, Garbe C, et al. Safety of ipilimumab in patients (pts) with untreated, advanced melanoma alive beyond 2 years: Results from a phase III study. J Clin Oncol. 2012;30(15s): abstract 8512.
5. National Comprehensive Cancer Network (NCCN) Web site. "NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines): Melanoma." Available at: http://www.nccn.org/professionals/physic... Accessed on September 19, 2012.
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