Novartis Submits sBLA and Type II Variation for Kymriah as Third Indication in Relapsed/Refractory Follicular Lymphoma
Oct 28, 2021 02:21
CST Updated
02:21
Novartis
Drug Development and Manufacturing
FDA
U.S. Food and Drug Administration
European Medicines Agency
The European Medicines Agency (EMA) is a decentralized agency of the European Union (EU), located in London. It began operations in 1995. The agency is responsible for the scientific evaluation, supervision, and safety monitoring of medicines developed by pharmaceutical companies for use in the EU. By ensuring that all medicines available on the EU market are safe, effective, and of high quality, the EMA protects public and animal health in the 28 EU Member States and countries of the European Economic Area.
CAR-T Cell Therapy (Image source: childrenshospital.org)
October 27, 2021 /BioonBIOON/ --Novartis(Novartis) recently announced that the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have respectively accepted the applications for review.CD19 CAR-T Cell Therapy Kymriah (tisagenlecleucel)Supplemental Biologics License Application (sBLA) and Class II Change:For the treatment of adult patients with relapsed or refractory follicular lymphoma (r/r FL) who have received at least two prior therapies.。FDAPriority Review has been granted for this sBLA.
Previously,FDAgranted to Kymriah for the treatment of r/r FLRegenerative MedicineRegenerative Medicine Advanced Therapy (RMAT) designation; the European Commission (EC) has granted Kymriah Orphan Drug Designation (ODD) for the treatment of FL. If approved, Kymriah will provide an important treatment option for patients with r/r FL. Meanwhile,r/r FL will also become Kymriah's third B-cell malignancy indication.TumorIndications。
Kymriah is a CD19-directed genetically modified autologous T-cell cellular immunotherapy.. Unlike conventional small-molecule or biologic therapies, CAR-T cell therapy is a living T-cell therapeutic product.The mechanism of action of Kymriah involves genetically modifying a patient's T cells to express a chimeric antigen receptor (CAR) designed to target the CD19 antigen., CD19 is expressed on various bloodTumorCell surface antigen proteins, including B-cell lymphoma, andLeukemiaCell.
Kymriah is AmericanFDAThe first approved CAR-T cell therapy, currently marketed in 30 countries worldwide, with over 345 certified treatment centers.Kymriah is a one-time treatment designed to enhance the patient's immune system to fight cancer. Currently, the approved indications for Kymriah include: (1) treatment of pediatric and young adult patients (up to 25 years of age) with relapsed or refractory acute lymphoblastic leukemia (r/r ALL); (2) treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL).
This new indication application is based on positive data from the pivotal Phase 2 ELARA trial. This is a single-arm, multicenter, open-label Phase 2 trial evaluating the efficacy and safety of Kymriah in adult patients with R/R FL. The data indicate that the study observed in r/r FL patients who had previously received multiple lines of therapy (median: 4 [range: 2–13])Robust Response Rates: Complete Response (CR) Rate of 66%, Overall Response Rate (ORR) of 86%。The safety profile was highly favorable; within the first 8 weeks following infusion, no patients experienced Kymriah-related cytokine release syndrome (CRS) of grade 3 or higher.. Data from this trial were presented earlier this year at the 2021 American ClinicalTumorVirtual Annual Meeting of the Society (ASCO)ConferencePublished on.
NovartisExecutive Vice President andTumorand Global Head of Hematology Development Jeff Legos said: "This is a significant milestone in our mission to provide Kymriah to adult patients with relapsed or refractory follicular lymphoma. Receiving orphan drug designation from the EC andFDApriority review, highlighting the significant unmet needs and urgency in these patients. Kymriah demonstrated impressive results in the ELARA trial, and we hope to provide a unique and potentially curative treatment, thereby minimizing the burden.” (Bioon.com)