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Novarte's CAR-T cell therapy Kymriah (tisagenlecleucel) treats recurrent or incurable follicular lymphoma, and an interim analysis of the ELARA Phase 2 trial shows that Kymriah has reached the primary endpoint of total remission rate (CRR).
the rate of complete remission is the evaluation criterion of treatment response in patients with follicle lymphoma.
Kymriah is the first CAR-T treatment approved by the U.S. Food and Drug Administration (FDA) in August 2017 and has been approved for two types of ancropathy: recurrent or incurable acute lymphoblastic leukemia and recurrent or incurable adult diffuse large B-cell lymphoma.
: CAR-T cell therapy is treated by separating the patient's own T-cells, reprogramming and amplification in the body, and then returning them to the patient for treatment.
the FDA has approved two CAR-T products, Kymriah of Novarda and Yescarta of Gilead.
both products are CD19s that target the surface of B cells, but the design of the CAR varies.
Kymriah's co-stimulus domain is 4-1BB, while Yescarta's co-stimulation domain is CD28.
Kymriah was developed by Novarhua in partnership with the University of Pennsylvania, and according to Novarhua, the results of the ELARA trial will be included in regulatory documents, which are expected to be submitted to the FDA in 2021 and in Europe shortly.
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