Express Innovative PI3Kδ Inhibitor obtained FDA priority review qualification, Cinda Biotech owns rights and interests in Greater China

▎Editor of WuXi AppTec content team On November 1, 2021, Incyte announced that the US FDA has accepted the New Drug Application (NDA) for parsaclisib
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Parsaclisib is a new-generation phosphatidylinositol 3-kinase δ (PI3Kδ) oral inhibitor that is under research and is used for the treatment of relapsed/refractory follicular lymphoma, marginal zone lymphoma and sheath Patients with cell lymphoma
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It is worth mentioning that in December 2018, Innovent and Incyte reached a cooperation and obtained the development and commercialization rights of parsaclisib in Greater China
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 The FDA also granted priority review status for parsaclisib for the treatment of adult patients with relapsed/refractory marginal zone lymphoma and adult patients with treated mantle cell lymphoma who have received at least one CD20 inhibitor treatment
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Non-Hodgkin's lymphoma (NHL) is a type of cancer that originates from lymphocytes.
Follicular lymphoma, marginal zone lymphoma, and mantle cell lymphoma are all B-cell NHL
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Follicular lymphoma and marginal zone lymphoma are indolent or slow-growing lymphomas; mantle cell lymphomas are aggressive or fast-growing lymphomas
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For patients who relapse or are refractory after initial treatment, there are unmet medical needs in treatment options
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The PI3K signaling pathway plays an important role in regulating cell growth, movement, survival, metabolism and angiogenesis
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In human cancers such as breast cancer, colorectal cancer and blood cancer, almost all PI3K signaling pathways are dysregulated
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Studies have found that the overactivity of the PI3K signaling pathway is significantly related to tumor progression, increased tumor microvessel density, and enhanced chemotaxis and invasiveness of cancer cells.
Therefore, the PI3K signaling pathway is regarded by researchers as the development of cancer treatment drugs.
One of the key targets
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This application is based on positive data obtained from several phase 2 clinical trials
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Please see the following table for specific data: ▲The effect of Parsaclisib on different types of relapsed/refractory B-cell NHL (click to see the big picture, image source: reference [2]) In all trials, parsaclisib is generally well tolerated and safe Controllable features
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Incyte is planning to initiate a confirmatory phase 3 clinical trial
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"The FDA's acceptance of NDA represents an important milestone for treated NHL patients
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" said Dr.
Peter Langmuir, vice president of Incyte's tumor targeted therapy department.
"We look forward to working with the FDA to bring this innovative therapy to those who may benefit soon.
Patient
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"Reference: [1] Incyte Announces Acceptance of NDA for Parsaclisib for Three Types of Relapsed or Refractory Non-Hodgkin Lymphomas.
Retrieved November 1, 2021, from https:// [2] Incyte Announces Parsaclisib Treatment Results in High Rate of Rapid and Durable Responses in Patients with Relapsed or Refractory B-Cell Non-Hodgkin Lymphomas.
Retrieved November 1, 2021, from https://investor.
incyte.
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