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Drugs & Targets

Janssen submits Marketing Authorization Application to EMA seeking approval of cilta-cel for relapsed and/or refractory multiple myeloma

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The Janssen Pharmaceutical Companies of Johnson & Johnson has submitted a Marketing Authorization Application to the European Medicines Agency seeking approval of cilta-cel, an investigational B cell maturation antigen (BCMA)-directed chimeric antigen receptor T cell (CAR T) therapy, for the treatment of patients with relapsed and/or refractory multiple myeloma.

The application is supported by positive results from the ongoing phase Ib/II CARTITUDE-1 study, investigating the safety and efficacy of cilta-cel. The latest results were presented at the American Society of Hematology 2020 annual meeting. Clinical development is ongoing with patients enrolled globally in various studies, including sites in Europe, the United States of America, China and Japan.

In early 2021, EMA granted accelerated assessment for cilta-cel. Accelerated assessment is granted when a medicinal product is expected to be of major public health interest and a therapeutic innovation, and can significantly reduce the review timelines to evaluate an MAA.

A Biologics License Application seeking approval of cilta-cel for the treatment of relapsed and/or refractory multiple myeloma is currently under review by the FDA.

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