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    Home > Medical News > Medical World News > BMS liso-cel's MAA is increasingly competitive in the CAR-T market by EMA.

    BMS liso-cel's MAA is increasingly competitive in the CAR-T market by EMA.

    • Last Update: 2020-08-02
    • Source: Internet
    • Author: User
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    Author. Dopine recently announced that the European Medicines Agency (EMA) has accepted a marketing authorization application (MAA) from lisocabagene maraleucel (liso-cel, JCAR017).
    liso-cel is a CAR-T cell therapy developed by Juno (acquired by New Base in 2018 and acquired by BMS in 2019) with 4-1BB as a co-stimulation zone, in which CD4 plus and CD8 plus CAR-T cells have an accurate 1:1 The proportion of the liso-cel-declared indications in Europe are recurrent or refractive (R/R) diffuse large B-cell lymphoma (DLBCL), primary septum B cell lymphoma (PMBCL) and level 3B filter-foamly lymphoma (FL3B) that has previously been treated at least twice before.
    Liso-cel MAA is based on the results of a large-scale clinical trial of TRANSCEND NHL 001 in patients with third-line or multi-line R/R large B cell lymphoma (LBCL), as well as additional data from the TRANSCEND WORLD study.
    THE TRANSCEND NHL 001 was designed to assess the safety and efficacy of liso-cel, with a total of 269 cases of R/R LBCL (including DLBCL) patients enrolled.
    data show that the total remission rate (ORR) of liso-cel therapy was 73% and the total remission rate (CR) was 53% in patients with assessable efficacy (n-256).
    median follow-up for 12 months, median DOR has not yet reached (95% CI: 8.6-NR), median PFS is 6.8 months (95% CI: 3.3-14.1) and median OS is 21.1 months.
    median PFS and OS were not reached in patients whose condition was completely remissioned, and at 12 months, 65.1% of patients did not progress and 85.5% survived.
    safety, 79% (213/269) of all patients had adverse events of magnitude 3 or above (TEAE), such as neutrophil reduction (60%, 161/269), anemia (38%, 101/269) and platelet reduction (27%, 72/269).
    in addition, 42% (113/269) of patients have cytokine release syndrome (CRS), 30% (80/269) of patients have neurotoxicity (NT) events, although the incidence of CRS and NT above 3 levels is very low, and most CRS and NT are reversible.
    TRANSCEND WORLD is a single-arm, multi-queue, multi-center 2 study conducted in Europe and Japan to determine the efficacy and safety of liso-cel in patients with invasive B cells that are not Hodgkin's lymphoma (NHL).
    the main outcome indicators are the Overall Mitigation Rate (ORR), the secondary outcome indicators include safety, total mitigation rate, no event survival, no progression survival, overall survival, mitigation duration, pharmacokinetics and health-related quality of life.
    in addition to the European market, BMS has submitted listing applications for liso-cel in the United States and Japan in December 2019 and June 2020, respectively.
    also, liso-cel was previously granted breakthrough drug qualification (BTD) by the FDA, given priority drug qualification (PRIME) and accelerated review by the EMA, and awarded liso-cel in Japan as an orphan drug for the treatment of invasive B-NHL.
    analysts said liso-cel could generate about $1 billion a year in revenue if approved.
    currently, the FDA and EMA have approved two CAR-T cell therapies, Novartis's Kymriah and Gilead's Yescarta, the former approved for recurrent refractive b-cell acute lymphatic leukemia (B-ALL) patients under 25 years of age and DLBCL adult patients with secondary or above treatment, and the latter approved for two types of non-Hodgkin lymphoma, including DLBLandal almost non-primary cell cell patients.
    , Gilead's other CAR-T cell therapy KTE-X19 was also filed for listing in the United States in December 2019, and the drug is also an autonomous, anti-CD19, CAR-T cell therapy that has been awarded BTD and PRIME by the FDA and EMA, respectively, and is the first type of treatment for r/R-MCL.
    unfortunately, in February this year, the FDA extended liso-cel's BLA review cycle by three months to extend its PDUFA date until November 16, 2020, which makes KTE-X19 expected to surpass Liso-cel as the first to obtain FDA approval as the third CAR-T product approved by the FDA.
    , it is worth mentioning that in the European market, liso-cel still lags behind KTE-X19, and in February this year the EMA accepted KTE-X19's MAA.
    in Japan, there is only one commercial CAR-T product, Novartis's Kymriah.
    approved by Japan's Ministry of Health, Labour (MHLW) in March 2019 for the treatment of CD19-positive recurrent or refractive (r/r) B-cell acute lymphoblastic leukemia (ALL) and CD19-positive r/r diffuse large B-cell lymphoma (DLBCL), and the drug has been incorporated into Japan's health insurance.
    in addition, in March this year, MHLW submitted a new application for a new drug (NDA) for its CAR-T cell therapy Axi-Cel, Yescarta, which is recurrent/difficult-to-treat diffuse large B cell lymphoma and associated lymphoma.
    all the good, liso-cel is expected to be the third CAR-T cell therapy to be approved for sale in Japan.
    in China, no CAR-T product has been approved, but Fosun Pharma's Iquillaanda and the drug-based Giuno's Riquilunsai (research and development code: JWCAR029) has been reported in the domestic production.
    one of the Iquilillsais is a CAR-T product introduced by Fosun Pharma from Kite Pharmaceuticals, or Yescarta.
    Ruikilensay is a CAR-T product developed by The U.S. giant company JCAR017 on the basis of the drug- and pro-Yuan.
    in addition to the car-T products mentioned above, BMS/Bluebird submitted to the FDA in March this year the BLA targeting BCMA's CAR-T therapy, cabeta vicegeneucel, for the treatment of multiple myeloma patients who have undergone at least three treatments, but the FDA declined to accept THE BLA in May.
    however, the MAA of idecabagene vicleucel was accepted by the EMA in May this year.
    well, idecabagene vicleucel is expected to become the world's first approved CAR-T cell immunotherapy to target BCMA.
    , Novartis Yescarta is doing better on the two CAR-T products it has listed, with sales of $456 million in 2019 and Kymriah with sales of $278 million in 2019.
    expects car-T market competition to become more intense in the future with the approval of new CAR-T products.
    .
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