Lantheus Holdings今日宣布,其研发的Bravnetsa™(Lutetium Lu 177 Dotatate)已获得美国食品药品监督管理局(FDA)的最终批准。这一里程碑式的决定,标志着Bravnetsa™成为FDA认定的唯一一款在生物等效性和治疗等效性上均与Lutathera®(Lutetium Lu 177 Dotatate)相匹配的放射性药物,专门用于胃肠胰神经内分泌肿瘤(GEP-NETs)的治疗。
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