The European Commission (EC) has granted Bristol Myers Squibb (BMS) approval for its Opdivo (nivolumab) combination with gemcitabine and cisplatin for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma.

The EC approved the therapy based on results from the CheckMate-901 trial (NCT03036098). The decision follows a US Food and Drug Administration (FDA) approval for the Opdivo combination therapy based on the same data in March 2024.

However, Opdivo faces an upward climb as the urothelial cancer market is already dominated by Merck & Co (MSD)’s checkpoint inhibitor Keytruda (pembrolizumab) and Pfizer’s antibody-drug conjugate Padcev (enfortumab vedotin).

The Phase III CheckMate-901 data readout demonstrated that the Opdivo combination group had a longer overall survival compared to the standard-of-care group. Furthermore, the treatment group exhibited a median survival of 21.7 months in contrast with 18.9 months in the other patient group.

In a 29 May press release, Dr Michiel Van der Heijden, a research group leader at the Netherlands Cancer Institute, said: “These findings are significant and reinforce that concurrent Opdivo and chemotherapy should be considered as a new standard of care for the first line treatment of eligible patients with this difficult-to-treat cancer.”

The EC approval is valid in all EU member states, including Iceland, Liechtenstein and Norway. Previously, there were no marketed therapies that improved overall survival in patients with unresectable or metastatic urothelial carcinoma in combination with cisplatin chemotherapy.

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The EC has previously approved BMS’ monoclonal antibody therapy for the adjuvant treatment of adults with muscle-invasive urothelial carcinoma with tumour cell PD-L1 expression ≥1% who are at a high risk of recurrence after undergoing radical resection. Furthermore, the combination is marketed in the EU for the treatment of ten other cancer types, including gastric, colorectal and non-small cell lung cancers.

According to GlobalData, there are currently six marketed therapies for the treatment of urothelial cancer in the EU, including Keytruda, Roche’s Tecentriq (atezolizumab), and Padcev. A few therapies are also approaching approval, reaching the later stages of the clinical pipeline.

GlobalData is the parent company of Pharmaceutical Technology.

AstraZeneca is investigating its checkpoint inhibitor Imfinzi (durvalumab) in combination with gemcitabine and chemotherapy in the Phase III NIAGARA clinical study (NCT03732677) for the treatment of muscle-invasive bladder cancer.