Follicular lymphoma, which is said to be the second most common form of non-Hodgkins lymphoma (NHL), is an indolent lymphoma and represents around 22% of NHL cases.
Claimed to be the first-ever FDA-approved CAR-T cell therapy, Kymriah has been designed to be a one-time treatment and the potential approval in r/r FL will be the third indication for the drug,
Kymriah was already indicated for /r pediatric and young adult acute lymphoblastic leukemia (ALL), as well as r/r adult diffuse large B-cell lymphoma (DLBCL).
The RMAT designation was provided for Kymriah based on preliminary clinical data from the ELARA ongoing multi-centre clinical trial.
The trial has been designed to determine the efficacy and safety of tisagenlecleucel in adult patients with relapsed or refractory FL.
Kymriah was developed in partnership with the Perelman School of Medicine at the University of Pennsylvania, a strategic alliance between industry and academia.
Novartis global drug development head and chief medical officer Dr John Tsai said: “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.”
Recently, Novartis has entered into an agreement with the FDA to conduct a clinical trial with the hydroxychloroquine in hospitalised COVID-19 patients.
Sponsored by Novartis, the trial will recruit around 440 patients to assess the efficacy of malaria drug to treat hospitalised patients with COVID-19 disease.