CD19 CAR-T Cell Therapy! The first three total Yescarta was approved in Japan: treatment of recurrence / incurable large B cell lymphoma!

January 26, 2021 // -- Daiichi Sankyo recently announced that Japan's Ministry of Health, Labour (MHLW) has approved Yescarta (axicabtagene ciloleucel), a CD19-guided chiline antigen (CAR) T-cell therapy for the treatment of certain relapsed/refractic large B-cell lymphoma (LBCL) adults.
Yescarta has been approved in Japan for the treatment of relapsed/refractic large B-cell lymphoma (DLBCL), primary vertical B-cell lymphoma (PMBCL), post-transformation folytic lymphoma (tFL), and high-level B-cell lymphoma (HGBL).
Yescarta's use is limited to: (1) patients who have not previously received CD19 CAR-positive T cell infusion therapy;
Yescarta was developed by Kite Pharma, Gilead's cell therapy company, and in January 2017 it granted exclusive rights to the development, manufacture and commercialization of the CD19 CAR-T therapy in Japan.
, Yescarta approved the results of a key global clinical trial (ZUMA-1) conducted by Kite and a Phase 2 clinical study conducted by Phase 13.
In the Japan Phase 2 Open Label Single Arm Study, the efficacy and safety of 16 recurring or recurring large B-cell lymphomas (including DLBCL, PMBCL, tFL, HGBL) in Japanese patients treated with yescarta at the same dose as the ZUMA-1 study (2.0 x 10 x 6 square cells/kg).
results showed that the study's main endpoint, the Objective Mitigation Rate (ORR), was 86.7% (95% CI: 59.5-98.3%).
the overall safety and tolerance of Yescarta in the Japanese trials is consistent with what was observed in ZUMA-1.
dose-limiting toxicity was not observed.
all patients had adverse events (TEAE) during ≥-level treatment, the most common being a decrease in neutral granulocytes (81.3%), a decrease in lymphocytes (81.3%) and a decrease in plateplates (62.5%).
cytokine release syndrome (CRS) is a typical CAR T cell therapy TEAE, the occurrence rate of 81.3% (all levels), of which ≥3 CRS 1 case (6.3%).
neurological events, another typical CAR T-cell therapy for TEAE, were not observed.
car-T therapy is a live T-cell therapy product, unlike conventional small molecules or biological therapies.
Yescarta's principle is to genetically modify a patient's T-cells to express a chisellular antigen subject (CAR) designed to target antigen CD19, an antigen protein expressed on the surface of a variety of blood tumor cells, including B-cell lymphoma and leukemia cells.
Yescarta, approved by the FDA in October 2017, is the first CAR-T cell therapy to treat adult patients with relapsed or refractic large B-cell lymphoma (LBLC) with a specific adaptive disorder: for relapses or refractability of two or more system therapies in the past Treatment of adult patients with sexual LBCL includes diffuse large B-cell lymphoma (DLBCL), primary vertical large B-cell lymphoma (PMBCL), high-level B-cell lymphoma (HGBL), and DLBCL (i.e., transformative FL, tFL) derived from fable lymphoma (FL).
yescarta is not suitable for the treatment of primary central nervous system lymphoma.
in China, Yescarta (Ekili Lunsai Injections, codeNoted FKC876) was developed by Fosun Kate Biotech Co., Ltd. (FOSUN Kite), a joint venture between Shanghai Fosun Pharmaceutical Group and Kate Pharmaceuticals.
In mid-March, Fosun Kate announced that the National Drug Administration's (NMPA) Drug Review Center (CDE) had included a priority review of new drug listing applications (NDAs) for the treatment of second-line or above systems. Adult patients with relapsed or refractic large B-cell lymphoma after sexual therapy, including diffuse large B-cell lymphoma (DLBCL) non-special-fingered, primary vertical B-cell lymphoma (PMBCL), high-level B-cell lymphoma, and blistered lymphoma-transformed DLBCL.
Yikili Lunsai Injection (codenmost FKC876) is Fosun Kate's targeted CD19 in vitro CAR-T cell therapy product that introduced Yescarta (axicabtagene ciloleucel) technology from Kate Pharmaceuticals and is authorized to localize production in China.
the product is Fosun Kate's first CAR-T cell therapy product to be commercialized in China, and the first CAR-T cell therapy product officially accepted by the State Drug Administration (NMPA).
as a new cancer treatment, FKC876 can bring new hope and opportunity to patients with large B-cell lymphoma who have relapsed or are difficult to treat after receiving systemic treatment of second-line or above in China.
() Original source: YESCARTA® approved in Japan for Treatment of Patients with Relapsed/Refractory Large B-Cell Lymphomas