US FDA accepts application for burosumab for treatment of tumour-induced osteomalacia (TIO) for priority review

The application is seeking approval of burosumab for the treatment of FGF23-related hypophosphatemia associated with phosphaturic mesenchymal tumours (TIO) that cannot be curatively resected or localised. It includes data from two single-arm phase II studies (n=14 and n=13).

SPS commentary:

Burosumab is currently licensed in the UK for the treatment of X-linked hypophosphataemia with radiographic evidence of bone disease in children 1 year of age and older and adolescents with growing skeletons.


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