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The fda evaluated libtayo under priority review, which is reserved for medicines that represent potentially significant improvements in efficacy or safety in the treatment of serious conditions The fda has approved libtayo for the adjuvant treatment of adult patients with cscc at high risk of recurrence after surgery and radiation. An additional regulatory application is also under review in the european union, with a decision expected by the first half of 2026.
See important safety & full prescribing information.
The approval makes libtayo the first immunotherapy approved for use after surgery and radiation and may change how patients are treated earlier in their disease
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