Legend Biotech (LEGN) Announces BCMA CAR-T Therapy Cilta-cel Accepted for Accelerated Assessment in Europe for the Treatment of R/R Multiple Myeloma

February 1, 2021 7:15 AM EST

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Legend Biotech Corporation (NASDAQ: LEGN) (“Legend Biotech”), a global clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and other indications, announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has accepted a request for an accelerated assessment of the Marketing Authorisation Application (MAA) for the investigational B-cell maturation antigen (BCMA) targeted chimeric antigen receptor T-cell (CAR-T) therapy ciltacabtagene autoleucel (cilta-cel).

The request was made by Legend’s collaborator, Janssen Biotech, Inc. (Janssen). An accelerated assessment of the MAA is granted by the CHMP when a medicinal product is expected to be of major public health interest and therapeutic innovation.1

The MAA, which is targeted for submission in the first half of 2021, is based on results from the pivotal Phase 1b/2 CARTITUDE-1 study which evaluated the efficacy and safety of cilta-cel in the treatment of patients with relapsed and/or refractory multiple myeloma. Results from the study were presented (Abstract #177) at the 62nd American Society of Hematology Annual Meeting last month.2

“The acceptance of the request for an accelerated assessment is an important testament for the potential use of cilta-cel in treating patients with multiple myeloma,” said Ying Huang, PhD, CEO and CFO of Legend Biotech. “Together with our collaborator Janssen, we look forward to working with the EMA as we advance this treatment option toward market and provide new hope for patients.”

The accelerated assessment milestone in Europe follows the December 2020 announcement of initiation of a rolling submission of the Biologics License Application for cilta-cel to the U.S. Food and Drug Administration (FDA). Cilta-cel previously received a PRIority MEdicines (PRiME) designation from the European Commission in April 2019.



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