Cilta-cel Approval Requested in Japan for Heavily-treated Myeloma

Cilta-cel Approval Requested in Japan for Heavily-treated Myeloma

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Cilta-cel Approval Requested in Japan for Heavily-treated Myeloma

Janssen has submitted an application to regulators in Japan seeking the approval of ciltacabtagene autoleucel, an investigational CAR T-cell therapy also known as cilta-cel, to treat relapsed or refractory multiple myeloma patients. The submission to the Japanese Ministry of Health, Labour and Welfare (MHLW) specifically asks that cilta-cel be approval for patients who received at least three prior lines of therapies, including a proteasome inhibitor (PI), an immunomodulatory agent (IMiD), and a CD38 inhibitor. “Today’s submission is an encouraging step…

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