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Janssen has submitted a marketing authorization application to EMA seeking approval of its investigational BCMA-directed CAR-T cell therapy.
The Janssen Pharmaceutical Companies of Johnson & Johnson have submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) seeking approval of its investigational B-cell maturation antigen (BCMA)-directed chimeric antigen receptor T-cell (CAR-T) therapy.
Ciltacabtagebe Autoleucel (cilta-cel) has been developed for the treatment of relapsed and/or refractory multiple myeloma and is a differentiated CAR-T therapy with two BCMA-targeting single domain antibodies. Janssen’s MAA has been submitted based on positive Phase Ib/II data from the CARTITUDE-1 study, which is investigating the safety and efficacy of the therapy.
“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, global therapeutic area head, Oncology, Janssen Research & Development, LLC, in an April 30, 2021 press release. “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.”
“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,” added Mathai Mammen, global head, Janssen Research & Development, Johnson & Johnson, in the press release. “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 epitomizes how we strive to make a meaningful impact in the multiple myeloma landscape through advancing innovative treatments for patients,” stated Saskia De Haes, vice-president, EMEA Regulatory Affairs, Janssen R&D BE, in the press release. “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.”
The therapy is also under evaluation by FDA via a biologics license application.