Shots:
- The NMPA has approved Jaypirca (100 & 50mg) as a monotx. for the treatment of adults with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), expanding its use across all lines of therapy & regardless of prior covalent BTK inhibitor treatment
- Approval was backed by the P-III trials: BRUIN CLL-313 assessed Jaypirca in 282 pts with treatment-naïve CLL/SLL, while BRUIN CLL-314 assessed it in BTK inhibitor-naïve population (n= 662), which incl. relapsed & refractory and treatment-naïve pts
- BRUIN CLL-313 showed an 80.1% reduction in the risk of disease progression or death vs bendamustine + rituximab, while BRUIN CLL-314 met its 1EP of noninferior ORR vs ibrutinib in both the ITT & previously treated populations, with a numerically higher ORR; PFS data remain immature but showed favorable trend
Ref: PRnewswire | Image: Innovent | Press Release
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