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Novartis’ Kymriah Gets RMAT Designation

Investigational new indication to treat patients with relapsed or refractory follicular lymphoma

By: Contract Pharma

Contract Pharma Staff

Novartis was granted Regenerative Medicine Advanced Therapy (RMAT) designation by the U.S. FDA for 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 lymphoblas...

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