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EMA Validates BMS’s Type II Variation for Opdivo® (nivolumab)

Oct 30, 2023

Bristol Myers Squibb announced that the European Medicines Agency (EMA) has validated its type II variation application for Opdivo® (nivolumab) in combination with cisplatin-based chemotherapy as a first-line treatment for adult patients with unresectable or metastatic urothelial carcinoma.  This validation of the application confirms the submission is complete.

On 22 August 2023 the European Commission expanded the indication for Opdivo® as a monotherapy for adjuvant treatment of patients over 12 with stage IIB or IIC melanoma who have undergone complete resection.