Novartis AG was the first company to submit a chimeric antigen receptor T cell (CAR-T) therapy for US FDA consideration and now with Kymriah (tisagenlecleucel) it is the first to win approval for the game-changing treatment modality, and thus set the pricing bar for competing CAR-T products.
The FDA approved Kymriah on Aug. 30 – about a month earlier than the Oct. 3 user fee date – for the treatment of pediatric and young adult patients (up to age 25) with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or has relapsed after at least two prior lines of therapy
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