FDA ap­proves high-risk neu­rob­las­toma treat­ment for kids and adults

The FDA ap­proved US WorldMeds’ eflor­nithine as a ther­a­py to re­duce the risk of re­lapse in adult and pe­di­atric pa­tients with high-risk neu­rob­las­toma who have demon­strat­ed at least a par­tial re­sponse to a pri­or treat­ment, in­clud­ing an­ti-GD2 im­munother­a­py.

The agency said on Wednes­day that this is the first drug ap­proved that’s “in­tend­ed to re­duce the risk of re­lapse in pe­di­atric pa­tients” with high-risk neu­rob­las­toma. The FDA ap­proved eflor­nithine, now brand­ed as Iwil­fin, based on an ex­ter­nal­ly con­trolled tri­al with end­points of event-free sur­vival and over­all sur­vival.

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