The European Commission has approved ipilimumab, a novel immunotherapy, for the second-line treatment of adult patients with previously treated, advanced melanoma, the medicine’s manufacturer said July 14.
Ipilimumab (Bristol-Myers Squibb’s Yervoy) was recommended in May by the European Medicines Agency for the indication, and was approved in March by the U.S. Food and Drug Administration. Ipilimumab, a monoclonal antibody, causes tumor cell death by blocking the inhibitory signal of CTLA-4, resulting in T-cell activation, proliferation, and lymphocyte infiltration into tumors.
The medication was shown in one manufacturer-funded, randomized, controlled trial to prolong overall survival for an unprecedented amount of time for people with metastasized unresectable melanoma (N. Engl. J. Med. 2010; 363:711-23).
Patients in the trial (n = 676) received ipilimumab plus glycoprotein 100 (gp100), gp100 alone, or ipilimumab alone, in four intravenous infusions at 3 mg/kg of body weight over 12 weeks. Patients who received the combination therapy or ipilimumab alone saw a median overall survival of about 10 months, compared with 6.4 months for those receiving only gp100. Gp100 was not found to improve the efficacy of ipilimumab.
Responding patients could receive additional courses of ipilimumab, and more than a fifth of patients in the ipilimumab arms survived 2 years or longer.
Adverse reactions to ipilimumab were mostly immune related, and included enterocolitis, hepatitis, dermatitis (including toxic epidermal necrolysis), neuropathy, and endocrinopathy.
European Commission approval means that ipilimumab will be available to patients throughout the European Union. However, pricing may differ, depending on procurement and patient-access schemes in each country. In the United States, ipilimumab is estimated to cost $120,000 per course of treatment.