Eli Lilly's Non-Covalent BTK Inhibitor Pirtobrutinib (Jaypirca) Nominated for Priority Review in China for Relapsed/Refractory Mantle Cell Lymphoma

On October 16, the CDE website showed that Eli Lilly's new generation non-covalent Bruton's tyrosine kinase (BTK) inhibitor Pirtobrutinib tablets are proposed to be included in the priority review, for the indication of monotherapy in adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have previously received BTK inhibitor treatment.

Pirtobrutinib is a highly selective, non-covalent (reversible) BTK inhibitor with a novel binding mechanism. Pirtobrutinib can re-establish BTK inhibition in MCL patients previously treated with covalent BTK inhibitors (including ibrutinib, acalabrutinib, or zanubrutinib) and continue the benefits of targeting the BTK pathway.

According to the previously released Phase I/II BRUIN study data by Eli Lilly, the overall response rate (ORR) reached 50% among 120 patients with relapsed or refractory MCL who had previously been treated with covalent BTK inhibitors, with 13% of patients achieving complete response (CR).

In January 2023, the FDA granted accelerated approval to Pirtobrutinib (brand name: Jaypirca) for third-line or later treatment (including prior treatment with other BTK inhibitors) in adult patients with relapsed or refractory mantle cell lymphoma (MCL). Notably, Pirtobrutinib is the world’s first and only non-covalent (reversible) BTK inhibitor to receive FDA approval.

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