Legend Biotech has announced the submission of a Type II variation application to the European Medicines Agency (EMA) for CARVYKTI (ciltacabtagene autoleucel or cilta-cel), based on data obtained from the CARTITUDE-4 study (NCT04181827).

This study focuses on the treatment of adult patients with relapsed and lenalidomide-refractory multiple myeloma who have undergone one to three prior lines of therapy. The application was filed by Janssen-Cilag International, a collaborator of Legend Biotech responsible for the development and commercialization of cilta-cel.

Legend Biotech, a biotechnology company headquartered in New Jersey and listed on Nasdaq, is dedicated to the development, manufacturing, and commercialization of innovative therapies for life-threatening diseases.

CARVYKTI is a genetically modified autologous T cell immunotherapy that targets B-cell maturation antigen (BCMA). It is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have undergone four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

The Type II variation application for CARVYKTI is supported by data obtained from the CARTITUDE-4 study, which is a phase 3 clinical trial that compares the efficacy and safety of cilta-cel with pomalidomide, bortezomib, and dexamethasone (PVd) or daratumumab, pomalidomide, and dexamethasone (DPd) in the treatment of patients with relapsed and lenalidomide-refractory multiple myeloma who have received one to three prior lines of therapy.

Ying Huang — Legend Biotech CEO said: “We are committed to investigating the full potential of CARVYKT across patient populations, including in earlier lines of treatment.

“I am proud of the efforts that Legend Biotech and our collaborator, Janssen, continue to make to potentially bring CARVYKTI to a broader range of patients.”

CARTITUDE-4 is the first randomized Phase 3 study to assess the effectiveness of cell therapy as early as after the first relapse in multiple myeloma.

The results from the CARTITUDE-4 study will be presented in an oral session at the upcoming American Society of Clinical Oncology (ASCO) Annual meeting on June 5, 2023. Additionally, these findings will also be presented at the 2023 European Hematology Association (EHA) Hybrid Congress.

Furthermore, a regulatory filing to the US Food and Drug Administration is being planned.

  bortezomib, CARVYKTI, ciltacabtagene autoleucel, Daratumumab, Dexamethasone, European Medicines Agency, Hematology, Janssen-Cilag International, Legend Biotech, lenalidomide, Multiple myeloma, Oncology, Ying Huang