Janssen Submits Marketing Authorisation Application to the European Medicines Agency Seeking Approval of BCMA CAR-T Therapy Ciltacabtagene Autoleucel

The Janssen Pharmaceutical Companies of Johnson & Johnson announced that they have submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) 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 1b/2 CARTITUDE-1 study, investigating the safety and efficacy of cilta-cel.[1],2 The latest results were presented at the American Society of Hematology (ASH) 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.1,[2]

“Despite advances in the treatment of multiple myeloma, there remains a high unmet need, especially for patients whose disease continues to progress,” said Peter Lebowitz, M.D., PhD., Global Therapeutic Area Head, Oncology, Janssen Research & Development, LLC. “Through our collaboration with Legend Biotech, we continue to expedite the development of cilta-cel with a focus and priority on the patients who may benefit from this novel immunotherapy in the future.”

CAR‑T therapy is a highly personalised treatment platform where a patient’s own T-cells are re-programmed to recognise and attack cancer cells.[3] In early 2021, the EMA granted accelerated assessment for cilta-cel.[4] 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.[5]

“Janssen has been advancing the science of oncology for more than 30 years, and we see great opportunity in the area of cell therapy and through our innovative platforms,” says Mathai Mammen, M.D., Ph.D., Global Head, Janssen Research & Development, Johnson & Johnson. “We are continuing to harness our deep scientific expertise in multiple myeloma as we look to advance therapeutic options, deepen clinical responses, and drive towards improved patient outcomes.”

“Today’s submission to the EMA epitomises how we strive to make a meaningful impact in the multiple myeloma landscape through advancing innovative treatments for patients,” says Saskia De Haes, Vice President, EMEA Regulatory Affairs, Janssen R&D BE. “We look forward to working in partnership with health authorities, as part of the accelerated assessment process, to support these patients by ensuring timely access to the latest therapeutic options.”

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 United States Food and Drug Administration.



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