The US Food and Drug Administration (FDA) has granted Novartis expedited approval for its CAR-T cell therapy Kymriah (tisagenlecleucel) to treat people with relapsed or refractory (r/r) follicular lymphoma (FL) following two or more lines of conventional therapy.
As part of the Accelerated Approval Program, continued approval for the existing indication may be contingent on the confirmatory trial (s) demonstrating and explaining clinical benefits. Kymriah can be administered in an outpatient program, giving patients and caregivers more freedom and perhaps lowering the treatment burden.
Kymriah is now licenced for 3 indications and is the only CAR-T cell treatment that has received approval in both adult and paediatric settings. Kymriah was approved by the FDA based on the results of a 90-person, solitary, open-label Phase II ELARA clinical trial.
With a median follow-up of approximately 17 months, the trial evaluated Kymriah’s efficacy. According to the findings, 86% of those who had the Kymriah treatment had a reaction, with 68% having a full response. Kymriah’s safety profile was found to be extraordinary among the 97 participants who were evaluated for safety after a median follow-up of 21 months. There were 53% of participants in the study who had any-grade cytokine release syndrome (CRS) as described by the Lee scale, without any cases of high-grade CRS.
They are proud of the regulatory approval of a third application for Kymriah, said Victor Bulto, head of Novartis Innovative Medicines in the United States. They believe that this therapy strategy, which has the potential for long-term results, will assist patients with follicular lymphoma and also break the relentless cycle of treatment.
The latest breakthrough comes after Kymriah was approved by the European Commission to manage patients with r/r FL.