Mark Wildgust, PhD, Vice President, Oncology Global Media Affairs at Janssen, discusses positive data from the CARTITUDE-1 study assessing ciltacabtagene autoleucel (cilta-cel) for the treatment of adults with relapsed and/or refractory multiple myeloma.

Multiple myeloma is a blood cancer associated with uncontrolled growth of plasma cells. Abnormal plasma cells – also known as myeloma cells – interfere with the production of healthy blood cells in the bone marrow. Myeloma cells also produce inactive clones of abnormal antibodies that may negatively affect the bones and kidneys. Symptoms of multiple myeloma may include: bone pain (particularly in the chest and spine), frequent infections, weakness or numbness in the legs, fatigue, confusion, excessive thirst, and constipation. While the disease is treatable, relapses are common and some patients are refractory to first line treatment.

The CARTITUDE-1 study is an ongoing Phase 1b/2, open-label, multi-center study evaluating the safety and efficacy of cilta-cel in adults with relapsed and/or refractory multiple myeloma. Preliminary data from CARTITUDE-1 were presented at ASH 2020 and indicated that a single low-dose infusion of cilta-cel leads to early, deep, and durable responses in heavily pretreated multiple myeloma patients. Data also suggests cilta-cel to have a positive safety profile consistent with previous studies

Given the positive preliminary results from this study, Janssen has initiated a rolling submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for cilta-cel for the treatment of adults with relapsed and/or refractory multiple myeloma.

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