J&J: marketing authorization application for erdafitinib in the European Union


(CercleFinance.com) – The Janssen pharmaceutical companies of Johnson & Johnson announced today the submission of a marketing authorization application (MAA) to the European Medicines Agency (EMA) aimed at obtaining the approval of erdafitinib for the treatment of urothelial carcinoma (UC) with FGFR3 alterations, with disease progression after a certain line of treatment.

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

‘For patients with advanced UC, including FGFR-driven tumors, outcomes remain poor and treatment options are limited; therefore, there is a need for new targeted therapies,’ said Martin Vogel, Head of Oncology EMEA Therapeutic Area at Janssen-Cilag GmbH.

‘We are excited about the prospect of commercializing innovative, personalized approaches for patients, as we work toward our broader goal: making this complex disease a more manageable and, ultimately, curable disease. ‘

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