Innovent's Jaypirca Gets Expanded NMPA Approval For CLL/SLL
(RTTNews) - Innovent Biologics, Inc. (IVBXF) announced that China's National Medical Products Administration (NMPA) has approved Jaypirca (pirtobrutinib) as a monotherapy for adults with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) across all lines of therapy, regardless of prior treatment with a covalent BTK inhibitor.
The expanded approval broadens Jaypirca's use to both treatment-naïve and previously treated CLL/SLL patients in China.
The approval is supported by data from the Phase 3 BRUIN CLL-313 and BRUIN CLL-314 studies.
In BRUIN CLL-313, Jaypirca demonstrated a statistically significant progression-free survival benefit versus bendamustine plus rituximab, reducing the risk of disease progression or death by 80.1%.
In BRUIN CLL-314, Jaypirca met the primary endpoint of noninferiority for overall response rate compared with ibrutinib in patients who were treatment-naïve or previously treated but BTK inhibitor-naïve.
Jaypirca also achieved a numerically higher overall response rate.
Jaypirca is a highly selective, non-covalent Bruton tyrosine kinase (BTK) inhibitor that targets both wild-type and C481-mutated BTK.
In mainland China, the drug was developed by Eli Lilly and is commercialized by Innovent.
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