Kymriah's follicular lymphoma extension of indication submitted to EMA
Novartis has announced that EMA accepted the submission application for the extension of indication for Kymriah (tisagenlecleucel) for the treatment of follicular lymphoma (FL) in adult patients with relapsed or refractory (r/r) follicular lymphoma (FL) after two prior lines of treatment.
This submission is based on data from the pivotal Phase II ELARA trial (NCT03568461), which investigated the efficacy and safety of Kymriah in adult patients with r/r FL. The trial met the primary endpoint with robust responses observed in heavily pretreated patients. The safety profile showed no patients experiencing grade 3 or higher cytokine release syndrome (CRS) related to Kymriah within the first 8 weeks following infusion.
This submission was also listed in the agenda of the CHMP meeting of October 2021, with the following indication wording: "Treatment of adult patients with follicular lymphoma (FL) after two or more lines of therapy who are refractory, or relapsed during or within 6 months after completion of anti-CD20 antibody maintenance, or relapsed after autologous haematopoietic stem cell transplantation (HSCT)".