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EU - Opdivo (nivolumab): annunciate le approvazioni di 3 nuove indicazioni
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BMS ha annunciato che la Commissione Europea ha approvato la Decisione per 3 estensioni delle indicazioni per Opdivo (nivolumab):
- in combination with fluoropyrimidine- and platinum-based chemotherapy for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) with tumor cell PD-L1 expression ≥ 1%
- in combination with Yervoy (ipilimumab) for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) with tumor cell PD-L1 expression ≥ 1%
- for the adjuvant treatment of adults with muscle-invasive urothelial carcinoma with tumor cell PD-L1 expression ≥1% who are at a high risk of recurrence after undergoing radical resection
Queste 3 decisioni della CE fanno seguito al parere positivo del CHMP concesso nel febbraio 2022.
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