Skip to main content
Premium Trial:

Request an Annual Quote

Novartis' Kymriah Nabs FDA Approval in Refractory Follicular Lymphoma

NEW YORK – The US Food and Drug Administration last week approved Novartis' autologous CAR T-cell therapy Kymriah (tisagenlecleucel) as a third-line option for patients with relapsed or refractory follicular lymphoma.

The FDA decided to grant Kymriah accelerated approval based on results from the Phase II ELARA trial, in which, after a median follow-up of 17 months, 86 percent out of 90 adult follicular lymphoma patients on the cell therapy responded and 68 percent experienced a complete response.

After a year post-Kymriah infusion, an estimated 85 percent of the patients who had a complete response were still responding to the therapy.

Novartis has also touted the drug's safety profile in terms of immunological toxicities. After a median of 21 months of follow-up, 53 percent of patients experienced cytokine release syndrome, though none of these were grade 3 or higher.

Importantly, in this patient population, Kymriah can be administered in the outpatient setting, which could improve access to the treatment. This differs from other autologous cell therapy indications, in which patients receive their infusion in the inpatient setting.

In the US, Kymriah would compete with Gilead's Yescarta (axicabtagene ciloleucel), for which the FDA granted accelerated approval last year as a third-line treatment for refractory follicular lymphoma. Bristol Myers Squibb's CAR T-cell therapy Breyanzi (lisocabtagene maraleucel) is also approved specifically for grade 3B follicular lymphoma patients.

Earlier this month, the European Commission approved Kymriah in this same relapsed or refractory follicular lymphoma patient population.