BRIEF—Novartis' Kymriah gains RMAT designation in follicular lymphoma

Novartis today announced that the US Food and Drug Administration granted Regenerative Medicine Advanced Therapy (RMAT) designation to Kymriah (tisagenlecleucel), for an investigational new indication to treat patients with relapsed or refractory (r/r) follicular lymphoma (FL).

Kymriah, which is designed to be a one-time treatment, is the first-ever FDA-approved CAR-T cell therapy.

The potential approval in r/r FL will be the third indication for Kymriah, which also has indications in r/r pediatric and young adult acute lymphoblastic leukemia (ALL), and r/r adult diffuse large B-cell lymphoma (DLBCL).

“This designation supports the advancement of Kymriah, which could potentially address an unmet need in certain patients with follicular lymphoma, as we strive to reimagine medicine at Novartis. These patients are often faced with the burden of several years of various treatments as their disease continues to progress.” said Dr John Tsai, head of global drug development and chief medical officer, Novartis.