IPILIMUMAB APPROVED BY EMA FOR FIRST LINE TREATMENT OF MELANOMA

The European Commission (EC) has approved ipilimumab (Yervoy, Bristol-Myers Squibb) for the first-line treatment of advanced (unresectable or metastatic) melanoma.

The decision comes 2 years after the initial approval by the EC for the use of ipilimumab in patients with previously treated advanced melanoma.

"This first-line approval of ipilimumab is important news for the many people with advanced melanoma across Europe who have not received prior treatment. Despite some advances in the first-line treatment of advanced melanoma, for many patients there remains a high unmet need for improved survival outcomes," said Ron Cooper, president of Bristol-Myers Squibb Europe, in a press statement.

"Ipilimumab is currently the only treatment for advanced melanoma that has demonstrated durable long-term survival in pretreated melanoma in a randomized phase 3 trial," noted Dirk Schadendorf, MD, PhD, from University Hospital Essen in Germany.

Some patients with advanced melanoma treated with ipilimumab are still alive up to 10 years later, according to a pooled analysis of 4846 patients recently presented at the European Cancer Congress.

"This is a huge paradigm shift in the treatment of melanoma from where we were just a few years ago," said Stephen Hodi, MD, assistant professor of medicine at the Dana-Farber Cancer Institute in Boston, at that meeting.

However, ipilimumab only has a response rate of 10% to 15% in patients with advanced disease, and it can cause severe and even fatal immune-based adverse reactions, such as enterocolitis, hepatitis, dermatitis (including toxic epidermal necrolysis), and endocrinopathy.

Adverse reactions related to the immune system are managed using protocol-specific guidelines.

The recommended regimen for ipilimumab is 3 mg/kg administered intravenously over a 90-minute period every 3 weeks for a total of 4 doses.

The extension of the marketing authorization was supported by data derived from phase 2 and 3 studies conducted in patients with advanced melanoma, as well as from 2 retrospective observational studies in first-line advanced melanoma patients treated with ipilimumab 3 mg/kg monotherapy, according to the company.