The European Medicines Agency Has Validated The Extension Application To Introduce Subcutaneous Administration For Bristol Myers Squibb's Opdivo (Nivolumab) And A New Strength (600 Mg/Vial) Across Multiple Previously Approved Adult Solid Tumor Indications
The European Medicines Agency Has Validated The Extension Application To Introduce Subcutaneous Administration For Bristol Myers Squibb's Opdivo (Nivolumab) And A New Strength (600 Mg/Vial) Across Multiple Previously Approved Adult Solid Tumor Indications
歐洲藥品管理局已驗證布里斯托-邁爾斯斯奎布的Opdivo（尼伯替尤）亞皮速射注射劑及新劑型（每瓶600毫克）在多種之前已批准的成人實體腫瘤適應症的延伸申請
- Validation is based on results from CheckMate -67T, the first Phase 3 trial of the subcutaneous formulation of Opdivo to evaluate and demonstrate noninferior pharmacokinetics and efficacy vs. its intravenous formulation
- Application seeks approval for subcutaneous nivolumab formulation to treat multiple Opdivo adult solid tumor indications in the European Union
- 驗證基於CheckMate-67T的結果，這是Opdivo皮下製劑的第一期3號臨床試驗，旨在評估和證明與其靜脈製劑相比的非劣藥代動力學和療效。
- 申請批准在歐盟治療多種Opdivo成人實體瘤指標的皮下尼伐單抗製劑。
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