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According to the key CARTITUDE-1 test data submission
Legend Biotechnology Company (Nasdaq stock code:Lane), a global clinical-stage biotechnology company that develops and manufactures novel therapies, today announced the submission of a New Drug Application (NDA) to the Japanese Ministry of Health, Labour and Welfare (MHLW) for ciltacabtagene autoleucel (cilta-cel) and its partner Janssen Pharmaceutical KK (Janssen). Cilta-cel is an investigative B cell maturation antigen (BCMA) directed chimeric antigen receptor (CAR)-T cell therapy for the treatment of relapses who have received at least three previous therapies (including proteasome inhibitors) Or refractory multiple myeloma adults (PI), immunomodulators (IMiD) and anti-CD38 antibodies.
This submission is based on the results of the Phase 1b/2 CARTITUDE-1 study conducted in the United States and Japan, which evaluated the efficacy and safety of cilta-cel in patients with relapsed or refractory multiple myeloma.1 Cilta-cel is currently undergoing regulatory review by multiple health authorities around the world, including the United States and Europe.
“Today’s submission is an encouraging step in our mission to provide potentially transformative cell therapy options for patients with multiple myeloma,” said Dr. Ying Huang, CEO and CFO of Legend Biotech. “We look forward to working closely with our partners Janssen and MHLW to provide cilta-cel to patients with relapsed or refractory multiple myeloma who have exhausted several standard treatments and are facing With a poor prognosis.”
About Ciltacabtagene Autoleucel
Cilta-cel is an investigational chimeric antigen receptor T cell (CAR-T) therapy. It was previously identified as JNJ-4528 in the United States and Europe, and as LCAR-B38M CAR-T cell in China. A comprehensive clinical development plan for the treatment of patients with relapsed or refractory multiple myeloma and early treatment. The design consists of a structurally differentiated CAR-T and two single domain antibodies targeting BCMA. In December 2017, Legend Biotech, Inc. and Janssen Biotech, Inc. (Janssen) signed an exclusive global licensing and cooperation agreement to develop and commercialize cilta-cel. In addition to the breakthrough therapy designation (BTD) in the United States in December 2019, cilta-cel also received the European Commission’s Priority Medicine (PRiME) designation in April 2019 and the BTD in China in August 2020 . In addition, the orphan drug cilta-cel received drug designation from the US FDA and the European Commission in February 2020 in February 2019. The application for approval of biologics for cilta-cel has been submitted to the US FDA, and the application for marketing authorization has been submitted to the European Medicines Agency.
About the CARTITUDE-1 study
CARTITUDE-1 (NCT03548207) Is 1b/2 issue, open label, polycentric…
The full story can be found on Benzinga.com
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