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PI3Kδ inhibitor has been granted priority review by FDA Cinda Biotech owns rights and interests in Greater China

 Last Update: 2021-12-09
 Source: Internet
 Author: User

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On November 1, 2021, Incyte announced that the US FDA has accepted the New Drug Application (NDA) for parsaclisib
.

Parsaclisib is a new-generation phosphatidylinositol 3-kinase delta (PI3K delta) 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

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
.

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
.

Follicular lymphoma and marginal zone lymphoma are indolent or slow-growing lymphomas; mantle cell lymphomas are aggressive or rapidly-growing lymphomas

The PI3K signaling pathway plays an important role in regulating cell growth, movement, survival, metabolism and angiogenesis
.

In human cancers such as breast cancer, colorectal cancer, and blood cancer, almost all PI3K signaling pathways are dysregulated

This application is based on positive data obtained from several phase 2 clinical trials
.

Please see the table below for specific data:

▲The effect of Parsaclisib in the treatment of different relapsed/refractory B cell NHL types (click to see the big picture, picture source: reference [2])

In all trials, parsaclisib was generally well tolerated and its safety profile was controllable
.

Incyte is planning to initiate a confirmatory phase 3 clinical trial

Reference materials:

[1] Incyte Announces Acceptance of NDA for Parsaclisib for Three Types of Relapsed or Refractory Non-Hodgkin Lymphomas.

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