Innovent and Ascentage Report NMPA Acceptance of NDA and Granted Priority Review Designation for Olverembatinib to Treat Chronic Myeloid Leukemia
Shots:
- The acceptance and Priority Review designation were based on the P-II pivotal study to evaluate the efficacy and safety of olverembatinib in 144 patients with CML-CP who are resistant & intolerant to first- and second-generation TKIs
- The results showed that olverembatinib can significantly improve the EFS vs control group and has met the pre-specified superiority criteria. The results will be presented at an upcoming academic conference
- Olverembatinib is a third-generation BCR-ABL inhibitor that is developed by Ascentage with support from the National Major New Drug Discovery & Manufacturing program which will be co-commercialized in China by both companies. The therapy has received ODD from the US FDA & EMA while FTD from the US FDA
Ref: PRNewswire | Image: Innovent
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