Somerset, NJ, April 5, 2024 - Legendary Bio (NASDAQ: LEGN) announced that the U.S. Food and Drug Administration (FDA) has approved CARVYKTI® (cidaghiorence, cilta-cel) for the treatment of patients with relapsed or refractory multiple myeloma (RRMM) who have received at least one prior line of treatment, including a proteasome inhibitor (PI) and an immunomodulatory (IMiD) agent and are resistant to lenalidomide.1 CARVYKTI® is the first and only drug approved for the treatment of relapsed or refractory multiple myeloma. therapy, including a proteasome inhibitor (PI) and an immunomodulatory (IMiD) and resistant to lenalidomide.1 CARVYKTI® is the first and only B-cell maturation antigen (BCMA)-targeted therapy, including CAR-T therapies, bispecific antibodies, and antibody-drug couplings (ADCs), to be approved for the second line of treatment for patients with multiple myeloma.
Dr. Ying Huang
Chief Executive Officer, Legendary Bio
The expansion of the CARVYKTI® indication is expected to change the treatment landscape for multiple myeloma, providing physicians and patients with a personalized immunotherapy that can be used in early treatment regimens. Multiple myeloma is an incurable and progressive hematologic tumor that causes patients to relapse and develop drug resistance, creating an urgent need for innovative treatment options. We are committed to improving the quality of life for patients with hematologic tumors and continue to work to develop cellular therapies that offer patients hope for a cure.
The FDA's approval was based on positive results from the CARTITUDE-4 study, which demonstrated that compared to the two standard-of-care regimens of pomalidomide, bortezomib, and dexamethasone (PVd) or daletuzumab, pomalidomide, and dexamethasone (DPd), CARVYKTI®significantly improved progression-free survival (PFS) in adult patients with relapsed and lenalidomide-resistant multiple myeloma who had received one to three prior lines of therapy, a statistically and clinically significant result. This approval comes on the heels of a unanimous recommendation (11-0) from the Oncology Drug Advisory Committee (ODAC) in favor of CARVYKTI®obtained after frontline treatment of the
Dr. ▏Surbhi Sidana
Blood and Bone Marrow Transplantation and Cellular Therapy, Stanford University School of Medicine
Assistant Professor of Medicine, M.D.
The results of the CARTITUDE-4 study demonstrated that infusion of cidaghiorence provided a significant clinical benefit over continued treatment with standard therapies in patients who had relapsed after one to three prior treatments. The FDA's approval of this expanded indication for cidaghiorence will allow more patients to access this innovative therapy earlier in the treatment process.
▏Birk Vanderweeën
Senior Vice President, Global Manufacturing & Supply, Legendary Bio
This expanded indication approval confirms the growing demand for CARVYKTI® and means that more patients will have access to this life-changing, personalized therapy. To ensure that we are able to meet the growing demand for customized therapies, our global manufacturing team and partners have expanded capacity and are focused on further scaling up operations to ensure that patients have access to CARVYKTI®.
for the past few years
Nanjing vigorously promotes the development of biomedical industry
depend on
Jiangbei New District, Jiangning District, Qixia District
Three Development Pilot Zones
Constructing the development pattern of gene and cell industry
- Jiangbei New District focuses on the development of genetic testing, antibody drugs, immune cell therapy, and targeted drug technology;
- Jiangning District focuses on the development of gene editing, cell therapy, cell storage, core reagents and cell culture media;
- Qixia District focuses on the development of cell therapy, antibody drug development, gene editing, cell storage, targeted drugs, functional proteins, and polymer organic materials.
Science and innovation companies are thriving
Innovations are coming to fruition
Further enhancement of the gene and cell industry
The internal drive for science, technology and innovation
The Action Plan for Promoting Industrial Strength in Nanjing (2023-2025) proposes to seize the new track of gene and cell future industry, which will focus on the key areas of new genomics technology, next-generation sequencing, gene editing, gene therapy, mini-nucleic acid drugs, and application of living organisms, and give full play to the advantage of data resources of the National Center of Healthcare Big Data (East) to carry out research and development on the key core technologies, and form industrial agglomeration and synergism in terms of key processes, upstream and downstream core materials, and product development to form industrial agglomeration and synergy, and promote the application and scale development of gene and cell technology.
