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.
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.
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).
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).
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 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).
Novartis Pharma’s JAK inhibitor Jakavi (ruxolitinib) passed a review by a key health ministry advisory panel for its label expansion into post-transplant graft-versus-host disease (GVHD)
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).
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
This guideline covers assessing and managing oesophago-gastric cancer in adults, including radical and palliative treatment and nutritional support.