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Ipilimumab approved for melanoma in EU
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The European Commission has approved ipilimumab for the treatment of advanced melanoma in adults.
Approval is based on data from a randomized, double-blind, phase 3 trial published in 2010 that demonstrated estimated long-term survival at 1 and 2 years (46% and 24% for ipilimumab arms vs. 25% and 14% for the comparator arm). Ipilimumab (Yervoy) is manufactured by Bristol-Myers Squibb.
“With the approval of Yervoy physicians now have an important new option to offer to patients with metastatic melanoma. This is a chance of not just months but potentially 3 to 4 years of prolonged survival for some patients in the treatment of metastatic melanoma,” Alexander Eggermont, MD, PhD, General Director, Institut Gustave Roussy, Paris, France, said in a press release. “There is hope that Yervoy’s novel mode of action, together with the fact that the recommended complete course of treatment with Yervoy (3 mg/kg) includes 4 infusions over 3 months, could potentially change the way we treat patients with previously treated advanced melanoma. It is an example of what can be done through unleashing the power of one’s own immune response.”
According to a company press release, Bristol-Myers Squibb plans to work closely with local health authorities to expedite the availability of the drug across the European Union. Prior to approval, the company provided ipilimumab to nearly 3,000 patients throughout Europe through Compassionate Use / Named Patient Programs.
Severe and fatal immune-related adverse reactions due to T-cell activation and proliferation are associated with ipilimumab. These immune-mediated reactions may involve any organ system; however, the most common severe immune-mediated adverse events are enterocolitis, hepatitis, dermatitis (including toxic epidermal necrolysis), neuropathy and endocrinopathy, according to the press release. Patients should be examined for signs and symptoms of adverse events and clinical chemistries should be evaluated, including liver function tests and thyroid function tests, at baseline and before each dose, the company suggests.
Corticosteroids, dose interruption or discontinuation and/or other immunosuppressants are used to manage adverse events associated with the drug.
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