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Today, Novarma announced that the European Commission (EC) has approved two adaptations of Kymriah (tisagenlecleucel, formerly known as CTL019), namely:
for the treatment of B-cell precursor acute lymphoblastic leukemia (ALL), and the condition is difficult to treat, or two or more recurrences of patients under 25 years of age
for the treatment of relapsed or recurring large B-cell lymphoma Adult patients (r/r DLBCL) (previously treated with two or more systems)
It is worth noting that on August 30, 2017, Kymriah became the first CAR-T cell therapy product approved in the United States, and a year later, Kymriah became the first CAR-T cell therapy product approved in Europe, and two adaptations were approved simultaneously.
approval is based on a review of two globally registered CAR-T clinical trials, ELIANA and JULIET, including patients from eight European countries. In these trials, Kymriah showed strong and long-lasting response rates and consistent safety in two groups of patients who were difficult to treat.ELIANA Study Data
Twenty-five research centers worldwide followed 75 patients with advanced B-cell lymphatic leukemia for three months or more after treatment with Kymriah, and the results showed that
81% of patients achieved full remission (95% CI: 71%-89%) and 80% of respondents were still in remission at 6 months. 60% of patients achieved complete remission (CR) and 21% achieved incomplete blood cell count recovery (CRi) CR. In those patients with remission, 100% did not detect micro-residual disease (MRD) in the bone marrow.
total lifetime (OS) was 90 per cent at 6 months and 76 per cent at 12 months. In this difficult-to-treat patient group, the medium OS was 19.1 months (95% CI:15.2-NE).
safety, 47 percent of patients in this clinical trial had a 3-4 cytokine storm and two deaths. 13% of patients experienced neuro-related side effects at levels 3-4 without cerebral edema.JULIET Study Data
In this globally critical Phase II clinical trial called JULIET, researchers evaluated the efficacy of Kymriah (CTL019) in patients with relapsed/refractic DLBCL, and clinical results confirmed the persistence of the therapy.key trial data show that
93 patients had an overall efficiency (ORR) of 52 per cent, a full remission rate (CR) of 40 per cent and a partial remission rate (PR) of 12 per cent in follow-up at least 3 months or earlier.
68 per cent and 65 per cent, respectively, for 6 and 12 months; And the mid-duration of the response is not reached at the data cut-off time, indicating the sustainability of the response. In all infusion patients (n s 111) (95% CI, 6.6-NE), the 12-month OS rate was 49% and the medium OS was 11.7 months.
safety, 22% of all patients treated experienced level 3 or 4 CRS within 8 weeks of entering Kymriah, and 12% had level 3 or 4 neurological disorders and were managed through supportive therapy. (Bio Valley)