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    Home > Biochemistry News > Biotechnology News > The world's fifth CAR-T is approved, BMS and Gilead each have two equal shares, Novartis is surpassed

    The world's fifth CAR-T is approved, BMS and Gilead each have two equal shares, Novartis is surpassed

    • Last Update: 2021-04-19
    • Source: Internet
    • Author: User
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    On March 27, the FDA official website announced that it had approved Abecma, the first CAR-T cell therapy targeting BCMA for the treatment of multiple myeloma (MM) in adults.


    Abecma is a CAR-T cell therapy targeting B cell maturation antigen (BCMA) jointly developed by bluebird bio and Celgene.


    Similar to the four previously approved CAR-T cell therapies, Abecma is also an autologous CAR-T cell therapy.


    Multiple myeloma is a rare blood tumor.


    According to the data presented by Abecm, in the safety and effectiveness trial for multiple/refractory myeloma, 127 patients had previously received at least 3 anti-myeloma treatments, and 88% of patients had received 4 or more.


    Judging from this data, Abecm's treatment effect is not as good as expected.


    Due to the risks of CRS and neurotoxicity, the FDA is approving Abecma for risk assessment and mitigation strategies (REMS).


    The FDA requires that hospitals and related clinics that use Abecma must be specially certified, and staff involved in the prescription, dispensing or management of Abecma must be trained to ensure that they can recognize and manage CRS, neurotoxicity and other side effects of Abecma.


    Previously, Abecma had been awarded the title of "Orphan Drug and Breakthrough Therapy" by the FDA, but the process of its approval for marketing has not been so smooth.


    The approval of Abecma was only one month after Bristol-Myers Squibb's last CAR-T cell therapy was approved.


    As of March this year, 5 CAR-T cell therapies have been launched globally.


    Although Novartis’s Kymriah was launched earlier than Gilead’s Yescarta, it is not as good as Yescarta due to higher pricing and no advantages in curative effects.


    There are also many domestic companies deploying CAR-T cell therapy.


    As an innovative therapy that has emerged in recent years, cell therapy has rapidly moved from the initial stage to the rapid development stage.


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