Legend Biotech Secures Approval for Cilta-cel in China
Wednesday, August 28, 2024
Legend Biotech a subsidiary of GenScript Biotect, has received approval from the China National Medical Products Administration (NMPA) for its cell therapy product, ciltacabtagene autoleucel (cilta-cel).
Cilta-cel is a CAR-T therapy, where patients' T cells are genetically modified to target and destroy myeloma cells expressing B-cell maturation antigen (BCMA). The therapy is administered via intravenous infusion and features a unique structure designed to enhance its effectiveness in eliminating tumor cells.
This innovative treatment is now approved for adult patients in China with relapsed or refractory multiple myeloma (MM) who have previously undergone at least three different therapies, including one proteasome inhibitor and one immunomodulatory agent. Cilta-cel offers a new option for patients who have not responded to standard treatments.
The approval of cilta-cel in China is a major milestone that will benefit many patients. Legend Biotech are committed to expanding our clinical research and making this innovative treatment more accessible to those in need.
This approval underscores GenScript and Legend Biotech's commitment to innovation. Legend Biotech on its achievement and expressed confidence that the company will continue to lead in cell therapy, pushing the boundaries of the industry with groundbreaking innovations.
The approval is based on the positive results from the CARTIFAN-1 Phase II clinical trial, which assessed cilta-cel's effectiveness and safety in patients with relapsed or refractory multiple myeloma. The study showed an overall response rate of 87.9% and a complete response rate of 79.3%, with long-lasting benefits observed in many patients.
Cilta-cel has proven to be a safe and effective therapy, offering significant benefits for multiple myeloma patients who have exhausted other treatment options. This approval not only highlights Legend Biotech's technological capabilities but also strengthens GenScript's position in the biotech industry. It represents a significant step forward in the development and commercialization of innovative cell therapies.
GenScript, with over 20 years of experience in life sciences and cell and gene therapy, continues to expand its influence in these fields. The company is dedicated to advancing the biotech industry through collaborations with global research institutions and industry partners, aiming to provide better treatment options for patients worldwide.
Source: genscript.com
