Shots:
- The US FDA has accepted NDA & granted priority review to sonrotoclax for adults with r/r mantle cell lymphoma following treatment with a BTK inhibitor
- NDA was supported by the global P-I/II (BGB-11417-201) assessing sonrotoclax in r/r MCL pts (n=125), which met its 1EP of improved ORR per IRC, with benefits seen across 2EPs, incl. CR rate, DoR, PFS; data to be presented at ASH’25
- BeOne will participate in the FDA’s Project Orbis for sonrotoclax, allowing parallel regulatory review across partner countries, with sonrotoclax’s NDA under NMPA’s review for r/r MCL & r/r CLL/SLL; BeOne will also submit P-I/II trial data in r/r MCL to additional regulators, incl. the EMA for potential approval
Ref: BeOne Medicines | Image: BeOne Medicines | Press Release
Related News: BeOne Medicines’ Sonrotoclax Receives FDA’s Breakthrough Therapy Designation for R/R Mantle Cell Lymphoma (MCL)
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