Ipilimumab (Yervoy) for Treating Metastatic Melanoma

Treatments for metastatic melanoma include systemic chemotherapy with dacarbazine, dacarbazine plus platinum agent, paclitaxel-based therapy, biotherapy (e.g., interleukin-2), chemobiotherapy (e.g., dacarbazine plus interleaukin-2), palliative surgery and palliative radiation therapy,1,2 and vemurafenib (Zelboraf®; Genentech, San Francisco, CA, USA), an oral BRAF (V-raf murine sarcoma viral oncogene homolog B1) inhibitor for patients with the static BRAF V600E mutation.3 Despite the variety of available therapies, strategies for treating metastatic melanoma remain controversial, and treatment options are suboptimal. Patients and clinicians are eager for new treatment options to address this substantial unmet need.4

Ipilimumab (Yervoy™, Bristol-Myers-Squibb, New York, NY, USA) is a fully human monoclonal antibody designed to stimulate T-cell antitumor response by targeting cytotoxic T-lymphocyte antigen-4 (CTLA-4) and inhibiting its action.5 Ipilimumab is believed to increase T-cell activity to increase tumor cell death (i.e., apoptosis).4,6 Ipilimumab is the first cancer immunotherapy to become commercially available that blocks CTLA-4 and is intended for use as either a first-line or second-line option for stage III or IV metastatic melanoma.5,7

Ipilimumab is also in clinical trials for treating various other cancers (e.g., breast, pancreas, bladder, small cell lung, non-small cell lung, castrate-resistant prostate, lymphoma) as a combination therapy with various agents, including gp100 peptide vaccine MDX-1379, bevacizumab (Avastin; Genentech/Roche), temozolomide (Temodar; Merck), dacarbazine (DTIC), fotemustine, and vemurafenib (Zelboraf; Plexxikon/Genentech).8-14

In March 2011, The U.S. Food and Drug Administration (FDA) approved ipilimumab for marketing for treating unresectable or metastatic melanoma.5 It was the first treatment approved in more than a decade for this condition.5 The European Union and Australia granted marketing approval in July 2011.15

The company capped the list price for a four-dose, full course of treatment with ipilimumab at $120,000, which is in...