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JAK inhibitor gets FDA approval again to treat fatal complications of stem cell transplantation

 Last Update: 2021-11-05
 Source: Internet
 Author: User

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Today, Incyte announced that the US FDA has approved its JAK inhibitor Jakafi (ruxolitinib) to expand its indications for the treatment of chronic graft-versus-host disease (GVHD) adults and children over 12 years old
.

These patients have received one or two systemic treatments

This approval is based on the results of a randomized, open-label Phase 3 clinical trial
.

The test results showed that compared with the best existing treatment, the overall response rate (ORR) of hormone-refractory GVHD patients treated with Jakafi at 24 weeks was 49.

GVHD is a potentially fatal complication that may occur after allogeneic stem cell transplantation
.

It is caused by transplanted cells that initiate an immune response and attack the recipient's organs

Jakafi is an oral "first-in-class" JAK1/JAK2 inhibitor
.

JAKs belong to the family of cytoplasmic tyrosine kinases, and their function is to transduce signals mediated by cytokines (such as interferon)

Reference materials:

[1] Incyte Announces FDA Approval of Jakafi® (ruxolitinib) for Treatment of Chronic Graft-Versus-Host Disease (GVHD).

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