-
Categories
-
Pharmaceutical Intermediates
-
Active Pharmaceutical Ingredients
-
Food Additives
- Industrial Coatings
- Agrochemicals
- Dyes and Pigments
- Surfactant
- Flavors and Fragrances
- Chemical Reagents
- Catalyst and Auxiliary
- Natural Products
- Inorganic Chemistry
-
Organic Chemistry
-
Biochemical Engineering
- Analytical Chemistry
- Cosmetic Ingredient
-
Pharmaceutical Intermediates
Promotion
ECHEMI Mall
Wholesale
Weekly Price
Exhibition
News
-
Trade Service
Recently, the US FDA accepted Ruxolitinib (Jakafi)'s Supplemental New Drug Application (sNDS) and granted it priority review as a potential treatment for patients with steroid refractory chronic graft-versus-host disease 12 years of age and older select.
As early as April 2019, Ruxotinib was approved by the FDA for the treatment of steroid-refractory acute graft-versus-host disease (GVHD) adults and children aged 12 years and older.
▌Chronic graft versus host disease
▌Chronic graft versus host diseaseHematopoietic stem cell transplantation is currently an important means to cure a variety of malignant blood diseases including leukemia.
Allogeneic hematopoietic stem cell transplantation is the implantation of one person's hematopoietic stem cells into another person's body, which is equivalent to transplanting another person's immune system at the same time.
Graft versus host disease is mainly divided into acute type and chronic type.
GVHD affects almost every organ system in the body.
In addition, GVHD has diverse clinical manifestations, some of which are similar to autoimmune and other immune diseases, such as scleroderma, Sjogren’s syndrome, primary biliary cirrhosis, and chronic immunodeficiency.
The clinical treatment options for chronic GVHD are very limited.
▌JAK inhibitor Ruxotinib
▌JAK inhibitor RuxotinibRuxotinib is an oral JAK1/JAK2 tyrosine kinase inhibitor, which was first approved for marketing in the United States in 2011.
It is worth mentioning that Belumosudil, an oral ROCK2 inhibitor, has also submitted a New Drug Application (NDA) to the FDA for the treatment of patients with chronic graft-versus-host disease.
▌Total remission rate is 50%! Help patients "move" the road safely
▌Total remission rate is 50%! Help patients "move" the road safelyThis sNDA is based on detailed data from a Phase 3 REACH3 study published at the 2020 American Society of Hematology (ASH) annual meeting.
Research indicates:
Research indicates:Compared with the best available therapy (BAT), the overall response rate (ORR) achieved by ruxotinib was significantly improved.
In addition to the primary endpoint ORR, Ruxotinib has shown advantages over BAT in terms of secondary endpoints such as failure-free survival (FFS), symptom improvement, and response duration.
◆ The median FFS of patients in the Ruxotinib treatment group has not yet reached, while it was 5.
◆ Compared with the BAT group, the best overall remission rate of Ruxotinib was higher, which was 76.
◆ According to the modified Lee Symptom Score Scale (mLSS), compared with BAT, 24.
◆ Ruxotinib did not reach the optimal median duration of overall response, while it was 6.
24 months in the BAT group.
Based on these results, Ruxotinib met all the primary and key secondary endpoints of the REACH3 study.
Graft versus host disease is fatal for patients who need hematopoietic stem cell transplantation, especially those who do not respond to steroids.
It is expected that this innovative JAK inhibitor will be approved for new indications as soon as possible, and will bring new treatment options for chronic GVHD.
Reference materials:
https:// haoeyou.
com/qita/20210226/5930.
html
