FDA Approves New Option for Melanoma in Pediatric Patients
The FDA has expanded the indication for Yervoy (ipilimumab) injection for intravenous use to include the treatment of unresectable or metastatic melanoma in pediatric patients 12 years of age and older.
The approval was based upon the findings from 2 trials: a dose-finding study of 33 patients aged 2 to 21 years with relapsed or refractory solid tumors and an open-label single-arm trial of 12 adolescents with previously treated or untreated Stage 3 or 4 malignant melanoma. The overall safety of the drug was consistent with the safety profile in adults. Of the 17 patients who were 12 years of age or older, 2 patients experienced objective responses.
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The approved dose for pediatric patients is 3 mg/kg, administered intravenously over 90 minutes every 3 weeks for a total of 4 doses.
Yervoy comes with a boxed warning of severe and fatal immune-mediated adverse reactions, the most common of which are enterocolitis, hepatitis, dermatitis, neuropathy, and endocrinopathy.
The most common adverse reactions included fatigue, diarrhea, pruritus, rash, and colitis.
U.S. Food and Drug Administration expands approval of Yervoy® (ipilimumab) to include pediatric patients 12 years and older with unresectable or metastatic melanoma [press release]. July 24, 2017. https://investors.bms.com/iframes/press-releases/press-release-details/2017/US-Food-and-Drug-Administration-Expands-Approval-of-Yervoy-ipilimumab-to-Include-Pediatric-Patients-12-Years-and-Older-with-Unresectable-or-Metastatic-Melanoma/default.aspx.