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The TIL therapy carries a boxed warning for treatment-related mortality, prolonged severe cytopenia, severe infection, and cardiopulmonary and renal impairment

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The closest safety dataset is the Increlex (mecasermin) clinical program , which followed 71 pediatric patients with severe primary IGFD on twice-daily SubQ rhIGF-1 for a mean of 3.9 years (some patients up to 11.5 years)

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