Novartis granted US FDA Priority Review for Kymriah(TM) (tisagenlecleucel), formerly CTL019, for adults with r/r DLBCL - Seite 3

About Kymriah Manufacturing
Kymriah is manufactured for each individual patient using their own cells at the Novartis Morris Plains, New Jersey facility. In the US, the target turnaround time for manufacturing Kymriah in the commercial setting is 22 days. The reliable and integrated manufacturing and supply chain platform for Kymriah allows for an individualized treatment approach on a global scale. The process includes cryopreservation of a patient's harvested (or leukapheresed) cells, giving treating physicians and centers the flexibility to initiate therapy with Kymriah based on the individual patient's condition. Building on the company's experience, having manufactured CAR-T cells for over 300 patients from 11 countries across various indications in clinical trials, it has demonstrated a reproducible product. Novartis continues to advance its CAR-T manufacturing expertise in Morris Plains where we have been supplying CAR-T cells for global clinical trials and where we continue to invest in support of the anticipated demand to meet the needs of patients.

Novartis has also successfully established the CTL019 manufacturing process at the Fraunhofer-Institut for cell therapy and immunology (Fraunhofer-Institut für Zelltherapie and Immunologie) facility in Leipzig, Germany, which currently supports the manufacturing of CTL019 for global clinical trials.

Novartis Leadership in Immuno-Oncology
Novartis is at the forefront of investigational immunocellular therapy as the first pharmaceutical company to initiate global CAR-T trials, and has significantly invested in CAR-T research and worked with pioneers in the field. Kymriah^TM, the first approved CAR-T cell therapy, is the cornerstone of this strategy. Active research programs are underway targeting other hematologic malignancies and solid tumors, and include efforts focused on next generation CAR-Ts that involve simplified manufacturing schemes and gene edited cells.

Kymriah^TM (tisagenlecleucel) US Important Safety information (for patients up to 25 years of age with B-cell precursor ALL that is refractory or in second or later relapse)
The full prescribing information, including Boxed WARNING, for Kymriah can be found at: https://www.pharma.us.novartis.com/sites/www.pharma.us.novartis.com/fi ...

Kymriah may cause side effects that are severe or life-threatening, such as Cytokine Release Syndrome (CRS) or Neurological Toxicities. Patients with CRS may experience symptoms including high fever, difficulty breathing, chills/shaking chills, severe nausea, vomiting and diarrhea, severe muscle or joint pain, very low blood pressure, or dizziness/lightheadedness. Patients may be admitted to the hospital for CRS and treated with other medications.