Novartis CAR-T cell therapy Kymriah approved for 2 B-cell malignancies

Recently, the EuropeanMedicines(EMA)Medicines(
CHMP) has issued a positive opinion recommending the approval of Novartis CAR-T cell therapy Kymriah for 2 Types of B-cell malignanciesthe two B-cell malignancies were:(1) patients with 25-year-old and below B-cell acute lymphoblastic leukemia (B-ALL) who had difficulty treating or relapsed after transplantation, and adultpatients with recurrent or refractory large B-cell lymphoma (R/DLB) who had been treated with 2 or more systemic therapies in the past.prior to that, the EMA had granted Kymriah prioritydrug(PRIME) for the treatment of R/R B-ALL pediatric patientsCHMP's positive comments are based on two key Phase II clinical studies conducted by Novartis, ELIANA and JULIET, in a group and patients from Europe, the United States, Australia, Canada and JapanELIANA is the first pediatric global CAR-T cell therapy registered clinical study, JULIET is the first multi-center global registered study to evaluate Kymriah's treatment of R/R DLBCL adult patients, and the largest global study to evaluate a CAR-T cell therapy treatment for DLBCLin the United States, Kymriah was approved in August 2017 as the world's first CAR-T cell therapy for children and young adults with B-cell precursor acute lymphoblastic leukemia (ALL) that is incurable or relapsed at least twiceMay 2018,FDA (re-approved Kymriah for use in adult patients with recurrent or refractory large B-cell lymphoma (LBCL), including DLBCL caused by diffuse large B-cell lymphoma (DLBCL), high B-cell lymphoma, and lactator lymphoma (FL), who have undergone two or more systemic treatments