EU - Opdivo (nivolumab): annunciate le approvazioni di 3 nuove indicazioni

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.