Enhanced performance in five key indicators highlights potential for reliable, fast, and high-quality treatment
[by Jin, Yu Jeong] Novartis Korea announced on September 15 that it presented a research abstract outlining its manufacturing experience and outcomes with its chimeric antigen receptor T-cell (CAR-T) therapy Kymriah (tisagenlecleucel) for patients with hematologic malignancies in Korea at the International Congress of the Korean Society for Blood and Marrow Transplantation (ICBMT 2025), held at BEXCO in Busan from September 11 to 13.
The study, which analyzed 574 cases of Kymriah manufactured and distributed to 14 CAR-T treatment centers in 안전한 바카라 사이트, systematically assessed the practical manufacturing capacity and supply performance of domestically produced CAR-T therapies.
In March 2021, Kymriah received regulatory approval in 안전한 바카라 사이트 for the treatment of post-transplant relapse, second relapse, or relapsed/refractory B-cell acute lymphoblastic leukemia (ALL), as well as relapsed or refractory diffuse large B-cell lymphoma (DLBCL) following two or more prior systemic therapies, in pediatric and young adult patients aged 25 years or younger. In April 2023, its indication was expanded to include adult patients with relapsed or refractory follicular lymphoma (FL) after at least two prior lines of therapy.
This analysis encompassed a total of 574 cases of Kymriah manufactured and supplied between March 2021 and March 2025, using five evaluation indicators: Manufacturing Success Rate (MSR), Sales Success Rate (SSR), Manufacturing Discontinuation Rate (TR), Out-of-Specification Rate (OOS), and Mean Time to Market (TAT).
According to Novartis 안전한 바카라 사이트, analysis of the key evaluation indicators demonstrated a steady improvement in MSR: 86.9% (n=164) in Year 1 (March 2021-December 2022), 93.4% (n=166) in Year 2 (January 2023-December 2023), 93.8% (n=193) in Year 3 (January 2024-December 2024), and 100% (n=51) in Year 4 (January 2025-March 2025).
The SSR also improved, rising from 91.3% in Year 1 to 100% in Year 4, while the TR declined from 8.1% to 0%, and the OOS decreased from 5% to 0%. Excluding cases in which delivery was delayed due to holidays or hospital requests, the TAT, defined as the interval from patient T cell collection to product delivery at the hospital, was shortened from 31.7 days (n=145) in Year 1 to 27.3 days (n=23) in Year 4.
The company attributed these improvements to sustained high manufacturing and delivery success rates, based on its established production capabilities and the operation of two manufacturing facilities in the United States and Switzerland. Novartis 안전한 바카라 사이트 further noted that the low rates of discontinuation and product disposal reflect the stable supply of high-quality, reliable treatments for patients with hematologic malignancies in 안전한 바카라 사이트.
"Kymriah is an innovative, personalized CAR-T therapy that delivers therapeutic efficacy and the potential for long-term survival through a single administration, representing a turning point for patients who are unresponsive to existing cancer treatments," stated Professor Yoon Dok-hyun of the Department of Oncology at Asan Medical Center.
"This presentation highlights advances in manufacturing capacity, including a reduced production timeline and enhanced manufacturing and delivery success rates. These improvements expand prescribing opportunities to a broader patient population and increase accessibility to CAR-T therapy, which are expected to further reinforce Kymriah's role in the treatment of refractory blood cancers in 안전한 바카라 사이트," Yoon further remarked.
"Our company is committed to continuously striving to improve treatment accessibility for 안전한 바카라 사이트n patients, not only by reinforcing manufacturing capabilities and infrastructure, but also through the establishment of a new CAR-T treatment center in 안전한 바카라 사이트," expressed Cho Hana, Country Medical Head at Novartis 안전한 바카라 사이트.
"This study reaffirms that Kymriah upholds rigorous quality standards both globally and domestically, ensuring the rapid and reliable delivery of treatments to patients. As a leading company in CAR-T therapy, Novartis 안전한 바카라 사이트 will remain dedicated to improving treatment accessibility so that a greater number of 안전한 바카라 사이트n patients can benefit from its clinical advantages," Cho further added.
Conversely, Novartis 안전한 바카라 사이트 is actively working to expand domestic CAR-T treatment centers and announced that Kymriah is now available at 16 institutions nationwide. These include Gachon University Gil Hospital, Dong-A University Hospital, Seoul National University Bundang Hospital, Soon Chun Hyang University Hospital Seoul, National Cancer Center, 안전한 바카라 사이트 University Guro Hospital, Chonnam National University Hwasun Hospital, Samsung Medical Center, The Catholic University of 안전한 바카라 사이트 Seoul ST. Mary's Hospital, Seoul National University Hospital, Severance Hospital, Asan Medical Center, 안전한 바카라 사이트 University Anam Hospital, Ulsan University Hospital, The Catholic University of 안전한 바카라 사이트 Yeouido ST. Mary's Hospital, and CHA Bundang Medical Center.