Janssen submits MAA to EMA for novel CAR-T cell therapy
pharmafile | May 5, 2021 | News story | Research and Development | EMA, EU, Janssen, multiple myeloma
Janssen have submitted a Marketing Authorisation Application (MAA) to the 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 submission of the application follows the positive results from the ongoing Phase 1b/2 CARTITUDE-1 study, investigating the safety and efficacy of cilta-cel.
Peter Lebowitz, MD, PhD, Global Therapeutic Area Head of Oncology, Janssen Research and Development, said: “Despite advances in the treatment of multiple myeloma, there remains a high unmet need, especially for patients whose disease continues to progress.
“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.”
Earlier this year, the 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.
Cilta-cel is a differentiated CAR-T therapy with two BCMA-targeting single domain antibodies. CAR-T cells are an innovative approach to targeting cancer cells by harnessing the power of a patient’s own immune system. BCMA is a protein that is highly expressed on myeloma cells.
Mathai Mammen, MD, PhD, Global Head of Janssen Research and Development, said: “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.
“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.”
Multiple myeloma is an incurable blood cancer that starts in the bone marrow and is characterised by an excessive proliferation of plasma cells. In Europe, 50,918 people were diagnosed with multiple myeloma in 2020, and more than 32,400 patients died.
Around 50% of newly diagnosed patients do not reach five-year survival, and approximately 10% of patients with multiple myeloma will die within one year of diagnosis. Although treatment may result in remission, unfortunately, patients will most likely relapse as there is currently no cure.
Saskia De Haes, Vice President, EMEA Regulatory Affairs, Janssen R&D, said: “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.
“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.”
Kat Jenkins
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