Chinese biopharmaceutical company Innovent Biologics Inc (HKEX:01801) announced on Sunday that China's National Medical Products Administration (NMPA) has approved a new indication for the non-covalent (reversible) Bruton's tyrosine kinase (BTK) inhibitor, Jaypirca (pirtobrutinib), for the treatment of adult patients with chronic lymphocytic leukaemia or small lymphocytic lymphoma (CLL/SLL) after at least one line of systemic therapy including a BTK inhibitor.
This approval is based on results from the international, multicentre, randomised, Phase 3 BRUIN CLL-321 study. BRUIN CLL-321 is the world's first randomised Phase 3 trial conducted in patients with CLL/SLL who had previously been treated with a covalent BTK inhibitor (cBTKi).
In October 2024, pirtobrutinib was approved in China as a monotherapy for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have previously received at least two prior systemic therapies, including a BTK inhibitor.
Pirtobrutinib was approved by the US Food and Drug Administration (FDA) in January 2023 as a non-covalent BTK inhibitor.
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