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J&J: authorisation to the European Medicines Agency

( - Janssen Submits Marketing Authorisation Application to the European Medicines Agency Seeking Approval of Erdafitinib for the Treatment of Patients with Locally Advanced or Metastatic Urothelial Cancer with Susceptible FGFR Alterations

Europe has one of the highest rates of bladder cancer in the world, with more than 203,000 patients diagnosed in 2020 alone.

Pending approval, erdafitinib, an investigational, once-daily oral pan-fibroblast growth factor receptor (FGFR) tyrosine kinase inhibitor,will become the first therapy targeting FGFR alterations in patients with metastatic urothelial carcinoma, one of Europe's most common cancers.

The submission is based on results from the Phase 3 THOR study, which were featured in a Late-Breaking Presentation Session at the 2023 ASCO Annual Meeting in June.

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A quel niveau sera le CAC40 à fin décembre 2023:

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