Swiss pharmaceutical giant Novartis (NYSE: NVS) has announced that it has received a new indication approval from the National Medical Products Administration (NMPA) for its Janus kinase (JAK) 1/2 inhibitor, Jakavi (ruxolitinib), as a treatment for patients with acute graft versus host disease (acute GVHD). This marks the first approval of its kind in the China market, covering patients aged 12 years and above who have failed to respond to glucocorticoids or other systemic therapies.
Jakavi’s History and Global Impact
Ruxolitinib, co-developed by Incyte and Novartis, was approved by the US FDA in 2011 as the first myelofibrosis therapy to gain US approval. In China, the drug was approved to treat myelofibrosis in March 2017 and was included in the National Reimbursement Drug List (NRDL) in November 2019. While Incyte holds the rights to ruxolitinib in the US under the brand name Jakafi, Novartis markets the drug as Jakavi in other regions.
Phase III REACH2 Study Results and Medical Guidelines
The global, multi-center Phase III REACH2 study demonstrated that ruxolitinib can provide rapid and lasting relief for patients with hormone-refractory acute GVHD. The study showed a 28-day total response rate of 62%, approximately 1.6 times that of the Best Accessible Therapy (BAT) group, and a 56-day continuous total response rate of 40%, approximately twice that of the BAT group. This significantly prolonged patient survival, with a median overall survival of 11.1 months compared to 6.5 months at BAT. The tolerability was good, and the safety profile was consistent with previous observations in other studies. Based on this high-quality evidence-based medical evidence, ruxolitinib has been recommended by the NCCN guidelines for Class 1 treatment of hormone-refractory acute GVHD.-Fineline Info & Tech
