Skip to content 
Heavy!
There is good news from this company in Nanjing
Legendary creatures
CARVYKTI® WAS APPROVED IN THE U.S. FOR SECOND-LINE INDICATIONS
On April 5, 2024 local time, Legend Biotech (NASDAQ: LEGN) announced in Somerset, New Jersey, USA that the U.S. Food and Drug Administration (FDA) has approved CARVYKTI® (cilta-cel) for the treatment of patients with relapsed or refractory multiple myeloma (RRMM) who have received at least one prior line of therapy, including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD) and resistant to lenalidomide1. CARVYKTI® is the first and only B-cell maturation antigen (BCMA)-targeted therapy approved for second-line treatment in patients with multiple myeloma, including CAR-T therapy, bispecific antibodies, and antibody-drug conjugates (ADCs).
Dr. Ying Huang
CEO of Legend Biotech
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 options. Multiple myeloma is an incurable and progressive hematologic cancer that causes patients to relapse and develop drug resistance, so innovative treatment options are urgently needed. We are committed to improving the quality of life of patients with hematological cancers and continue to strive to develop cell therapies that offer hope for a cure.
The FDA’s approval is based on the positive results of the CARTITUDE-4 study, which showed that CARVYKTI® compared to pomalidomide, bortezomib and dexamethasone (PVd) or daratumumab, pomalidomide and dexamethasone (DPd), two standard treatment regimensIt significantly improved progression-free survival (PFS) in adult patients with relapsed lenalidomide-resistant multiple myeloma who had received first- to third-line therapy in a statistically and clinically significant manner. The approval follows a unanimous recommendation (11-0) by the Advisory Committee on Oncology Drugs (ODAC) to support CARVYKTI’s® front-line treatment.
▏ Dr. Surbhi Sidana
Blood and bone marrow transplantation and cell therapy at Stanford University School of Medicine
Assistant Professor of Medicine, MD
Results from the CARTITUDE-4 study suggest that infusion of chidate-celleucel is associated with a significant clinical benefit of continued treatment with standard therapy in patients who have relapsed after one to three prior treatments. The FDA’s approval to expand the indication of cilta-cel will enable more patients to have access to this innovative therapy earlier in the treatment process.
▏Birk Vanderweeën
Senior Vice President of Global Manufacturing & Supply at Legend Biotech
This expanded indication approval confirms the growing demand for CARVYKTI® and means more patients will have access to this life-changing, personalized therapy. TO ENSURE WE CAN MEET THE GROWING DEMAND FOR CUSTOMIZED THERAPIES, OUR GLOBAL MANUFACTURING TEAM AND PARTNERS HAVE EXPANDED OUR CAPACITY AND ARE FOCUSED ON FURTHER SCALING OUR OPERATIONS TO ENSURE PATIENTS HAVE ACCESS TO CARVYKTI®.
Recently
Nanjing vigorously promotes the development of the biomedical industry
Relying on
Jiangbei New District, Jiangning District, Qixia District
Three development pilot areas
Construct a development pattern of gene and cell industry
- Jiangbei New Area focuses on the development of genetic testing, antibody drugs, immune cell therapy, targeted drug technology, etc.;
- 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 research and development, gene editing, cell storage, targeted drugs, functional proteins, polymer organic materials, etc.
Science and technology enterprises are booming
Innovations have been implemented
Further enhance the gene and cell industry
The internal driving force of scientific and technological innovation
The “Nanjing Action Plan for Promoting a Strong Industrial City (2023-2025)” proposes to seize the new track of the future industry of genes and cells, and will focus on key areas such as new genomics technologies, next-generation sequencing, gene editing, gene therapy, small nucleic acid drugs, and live biological applications. In terms of product development, industrial agglomeration and synergy will be formed to promote the application and scale development of gene and cell technology.
