12月28日,美国FDA宣布,批准百时美施贵宝开发的重磅PD-1抑制剂Opdivo(nivolumab)与含铂化疗联用作为手术前的新辅助疗法,随后单药作为手术后的辅助疗法,治疗可切除的非小细胞肺癌(NSCLC)成人患者。这些患者不携带EGFR或ALK基因变异。
新的Opdivo的注射形式预计将更方便患者,并有助于保护公司的销售侵蚀后,专利的静脉注射版本将在本十年晚些时候到期。
该注射剂的品牌为Opdivo Qvantig,已被批准用于治疗所有先前批准的成人实体瘤适应症,可以单独使用,也可以作为维持治疗或与化疗联合使用。
布里斯托尔首席商业化官Adam Lenkowsky在批准前对表示,该药将于1月初上市,定价将与IV版的定价相当。
静脉注射版药物的标价是,低剂量每次注射7635美元,为期两周,高剂量480毫克每次注射15269美元,为期四周。
由于癌症药物Revlimid和血液稀释剂Eliquis等老药的专利将于本十年晚些时候到期,这家制药商正依靠Opdivo Qvantig等新疗法来推动增长。
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