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US FDA approves ipilimumab

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Ipilimumab improved adjuvant treatment of patients with cutaneous melanoma

The US Food and Drug Administration (FDA) has approved ipilimumab (Yervoy injection), for the additional indication of adjuvant treatment of patients with cutaneous melanoma with pathologic involvement of regional lymph nodes of more than one mm who have undergone complete resection, including total lymphadenectomy.

The approval was based on improvement in recurrence-free survival (RFS) in a randomised (1:1), double-blind, placebo-controlled trial in 951 patients with resected Stage IIIA (lymph node >1 mm), IIIB, and IIIC (with no in-transit metastases) histologically confirmed cutaneous melanoma.

Safety data was evaluated in 945 patients (median age 51 years, 62 per cent male), who received ipilimumab 10 mg/kg (n=471) or placebo (n=474) administered as an intravenous infusion for four doses every three weeks followed by 10 mg/kg every 12 weeks beginning at week 24 up to a maximum of three years. Ipilimumab-treated patients received a median of4 doses and 36 per cent of patients received ipilimumab for longer than six months. Ipilimumab was discontinued for adverse reactions in 52 per cent of patients.

The most common adverse reactions included rash, pruritus, diarrhoea, nausea, colitis, vomiting, weight loss, fatigue, pyrexia, headache, decreased appetite, and insomnia.

Grade 3-5 immune mediated adverse reactions occurred in 41 per cent of ipilimumab-treated patients which included enterocolitis (16 per cent), hepatitis (11 per cent), endocrinopathy (eight per cent) dermatitis (four per cent), and neuropathy (1.7 per cent). The five treatment-related deaths were due to immune-mediated adverse reactions of enterocolitis, Guillain-Barré syndrome and myocarditis.

Patients should be assessed for signs and symptoms of enterocolitis, dermatitis, neuropathy, and endocrinopathy and evaluate clinical chemistries, including liver function tests, adrenocorticotropic hormone (ACTH) level, and thyroid function tests, at baseline and before each dose.

The recommended dose and schedule for ipilimumab for adjuvant treatment of melanoma is 10 mg/kg administered intravenously over 90 minutes every three weeks for four doses followed by 10 mg/kg every 12 weeks for up to 3 years. In the event of toxicity, doses are omitted, not delayed.

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