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Incyte announces acceptance and priority review of sNDA for Jakafi as a treatment for patients with chronic graft-versus-host disease.
Incyte has announced that the FDA has accepted for Priority Review the supplemental New Drug Application (sNDA) for ruxolitinib (Jakafi) for treatment of steroid-refractory chronic graft-versus-host disease (GVHD) in adult and pediatric patients 12 years and older.
CHMP recommends approval of Jakavi for acute graft-versus-host disease or chronic graft-versus-host disease.- Incyte
Incyte announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval of Jakavi (ruxolitinib) for the treatment of patients aged 12 years and older with acute graft-versus-host disease or chronic graft-versus-host disease (GVHD) and who have inadequate response to corticosteroids or other systemic therapies.
Positive results from pivotal ROCKstar trial of belumosudil to treat chronic graft-versus-host disease.- Kadmon Holdings Inc.
Kadmon Holdings, Inc. announced positive topline results from the primary analysis of ROCKstar (KD025-213), the pivotal trial evaluating belumosudil (KD 025) in patients with chronic graft-versus-host disease (cGVHD) who have received at least two prior lines of systemic therapy Belumosudil (KD025) achieved clinically meaningful and statistically significant Overall Response Rates (ORRs) of 73% with 200 mg once daily (QD) (95% Confidence Interval (CI): 60%, 83%; p<0.0001) and 74% with 200 mg twice daily (bid) (95% ci: 62%, 84%; p><0.0001).
Chronic Graft-versus-host Disease (cGvHD) Prophylaxis With or Without ATG Prior to Stem Cell Transplantation (SCT) From HLA-identical Siblings in Patients With Acute Leukemia
This multicenter, prospective phase III-study is to compare the administration of ATG FRESENIUS to the NON-administration of ATG FRESENIUS in...
FDA approves Orencia in combination with a calcineurin inhibitor and methotrexate for the prevention of acute graft versus host disease.
Bristol Myers Squibb announced that Orencia (abatacept) was approved by the FDA for the prophylaxis, or prevention, of acute graft versus host disease (aGvHD), in combination with a calcineurin inhibitor (CNI) and methotrexate (MTX), in adults and pediatric patients 2 years of age and older undergoing hematopoietic stem cell transplantation (HSCT) from a matched or 1 allele-mismatched unrelated donor (URD).
Rezurock patient-reported outcomes correlated with clinical response in chronic graft-versus-host disease.
Results from a pooled analysis of Rezurock (belumosudil) for the treatment of chronic graft-versus-host disease (cGVHD) show certain organ clinical responses correlated with clinically meaningful changes in patient-reported outcomes (PROs).
Incyte announces the FDA has extended the sNDA review period for ruxolitinib in chronic graft-versus-host disease (GVHD),
Incyte announced that the FDA has extended the review period for the supplemental New Drug Application (sNDA) for ruxolitinib (Jakafi) for the treatment of adult and pediatric patients 12 years and older with steroid-refractory chronic graft-versus-host disease (GVHD).
Phase III REACH3 study of Jakavi improved outcome in chronic graft-versus-host disease.- Novartis
Detailed results from the pivotal Phase III REACH3 study demonstrate Jakavi (ruxolitinib), from Novartis, significantly improved outcomes across a range of efficacy measures in patients with steroid-refractory/dependent chronic graft-versus-host disease (GvHD) compared to best available therapy (BAT).
Imbruvica is FDA approved to treat children with chronic graft versus host disease
AbbVie announced that the FDA approved the use of Imbruvica (ibrutinib) for the treatment of pediatric patients one year and older with chronic graft versus host disease (cGVHD) after failure of one or more lines of systemic therapy