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    Home > Active Ingredient News > Antitumor Therapy > Innovent's PI3Kδ inhibitor Parsaclisib was approved as a breakthrough therapy drug by CDE for the treatment of relapsed or refractory follicular lymphoma

    Innovent's PI3Kδ inhibitor Parsaclisib was approved as a breakthrough therapy drug by CDE for the treatment of relapsed or refractory follicular lymphoma

    • Last Update: 2021-04-14
    • Source: Internet
    • Author: User
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    On March 31, Innovent announced that its specific PI3Kδ inhibitor (Parsaclisib) has passed the publication period of the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA).
    Symptoms are relapsed/refractory follicular lymphoma (r/r FL).

    Follicular lymphoma is a common type of non-Hodgkin's lymphoma (NHL) and is one of the common hematological tumors.
    The standard first-line therapy is R-CHOP and similar programs.

    Approximately 20% will have early progress.
    For most newly-treated patients who are effective in treatment, they will inevitably enter the relapse and refractory stage after the disease is stable.

    Therefore, patients with relapsed or refractory follicular lymphoma still have unmet needs.

    IBI376 (Parsaclisib) is a new and potent selective inhibitor of PI3K enzyme, which is selective for the delta subtype.

    PI3Kδ is a key B-cell receptor signaling mediator, which is related to the growth, survival and proliferation of malignant B-cells.
    It has been proven to be effective and selective before clinical use, and has potential in the treatment of patients with malignant hematological tumors (such as lymphoma) Therapeutic effect.

    In December 2018, Innovent and Incyte reached a strategic cooperation on three drug candidates in clinical trials, including Parsaclisib.

    According to the terms of the agreement, Cinda Biotech owns the development and commercialization rights of Parsaclisib and two other drug candidates in Mainland China, Hong Kong, Macau and Taiwan.

    At the 62nd American Annual Meeting of Hematology (ASH) in 2020, Incyte reported the data of a clinical study of Parsaclisib in the treatment of relapsed/refractory follicular lymphoma.

    The study showed that the objective response rate (ORR) of Parsaclisib monotherapy in r/r FL patients (N=95) reached 75%, and the median progression-free survival (PFS) reached 15.
    8 months.

    Currently, Parsaclisib as a monotherapy for the treatment of non-Hodgkin lymphoma (follicular lymphoma, marginal zone lymphoma, and mantle cell lymphoma) and several phase 2 trials of autoimmune hemolytic anemia are in progress.

    In addition, a registered clinical trial of Parsaclisib and ruxolitinib in the treatment of patients with myelofibrosis is also ongoing.

    Incyte also plans to conduct trials to evaluate parsaclisib combined with tafasitamab in the treatment of non-Hodgkin's lymphoma (NHL) and chronic myeloid leukemia (CLL).

    End reference materials: [1] Cinda Biologicals selected onlookers in the past Nature: Immunotherapy known as the "anti-cancer star" may be a "crushing talisman" for this type of cancer patients.
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