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

▎The content team editor of WuXi AppTec today, Incyte announced that the US FDA has approved its JAK inhibitor Jakafi (ruxolitinib) for extended indications for the treatment of chronic graft-versus-host disease (GVHD) adults and over 12 years old Child patient
.

These patients have received one or two systemic treatments
.

This is another indication obtained by the drug after its topical formulation was approved by the FDA for the treatment of atopic dermatitis yesterday
.

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.
7%, which was significantly higher than that of the control group (25.
6%, p<0.
0001) )
.

This research has been published in the New England Journal of Medicine
.

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
.

There are two main forms of GVHD: acute GVHD, which usually occurs within 100 days of transplantation; and chronic GVHD, which usually occurs 100 days after transplantation
.

Both forms can affect multiple organ systems, including the skin, gastrointestinal tract, and liver
.

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)
.

JAK is also the main component of hematopoietic signals, and it is over-activated in the early stage of GVHD
.

Inhibition of JAK1/JAK2 can inhibit the release of inflammatory cytokines and reduce the pathological process of GVHD.
It can also inhibit the activation of donor T cells and reduce the immune response
.

It was approved by the FDA in 2019 for the treatment of steroid-refractory acute GVHD
.

Incyte has the development and promotion rights of Rucotinib in the United States, while Novartis has development and promotion rights outside the United States
.

"GVHD is the leading cause of morbidity and death after receiving allogeneic stem cell transplantation.
However, treatment options after first-line systemic therapy are limited
.

" said Dr.
Steven Stein, Chief Medical Officer of Incyte .
Understanding GVHD accumulates more scientific evidence to bring important advances in therapy for patients and the medical community
.

"Reference: [1] Incyte Announces FDA Approval of Jakafi® (ruxolitinib) for Treatment of Chronic Graft-Versus-Host Disease (GVHD) .
Retrieved September 22, 2021, from https:// Disclaimer: WuXi AppTec's content team focuses on introducing global biomedical health research progress
.

This article is for the purpose of information exchange only.
The opinions expressed in the article do not represent the position of WuXi AppTec, nor does it mean that WuXi AppTec supports or opposes the views in the article
.

This article is not a treatment recommendation either
.

If you need guidance on the treatment plan, please go to a regular hospital for treatment
.