Bristol-Myers Squibb announced that the Food and Drug Administration (FDA) has expanded the indication for Yervoy (ipilimumab) injection to include the treatment of unresectable or metastatic melanoma in pediatric patients aged ≥12 years. 

The approval was supported by data from a dose-finding study (n=33) in pediatric patients aged 2–21 years with relapsed or refractory solid tumors, and from an open-label, single-arm study (n=12) in pediatric patients aged 12–16 years with previously treated or untreated, unresectable Stage 3 or 4 malignant melanoma. Two of the 17 patients aged ≥12 years achieved objective responses. 

In general, the safety profile of Yervoy in children and adolescents was consistent with that seen in adults. Data were extrapolated for pediatric patients aged ≥12 years based on similarities of tumor biology and course of advanced melanoma with adults. 

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A population pharmacokinetic analysis (n=565) showed that Yervoy exposure in patients aged ≥12 years was similar to that in adults at the approved 3mg/kg dose given intravenously (IV) over 90 minutes every 3 weeks for a total of four doses. 

Yervoy, a cytotoxic T-lymphocyte antigen (CTLA-4)-blocking antibody, is already approved for the treatment of unresectable or ­metastatic melanoma in adults, and for the adjuvant treatment of cutaneous melanoma in patients with pathologic involvement of regional lymph nodes >1mm who have undergone complete resection, including total lymphadenectomy.

Yervoy is available as a 5mg/mL strength solution for IV infusion in 50mg and 200mg single-use vials. 

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