FDA approves second indication for Lilly’s BTK inhibitor Jaypirca

Acute lymphoblastic leukemia

Eli Lilly’s Jaypirca (pirtobrutinib) has been approved in the US for lymphocytic leukaemia or small lymphocytic lymphoma (CLL/SLL).

It has been granted approval by the Food and Drug Administration (FDA) to treat patients who have received at least two lines of therapy, including a Bruton’s tyrosine kinase (BTK) inhibitor and a BCL-2 inhibitor.

The decision was based on data from the BRUIN Phase I/II trial, in which adult patients with CLL/SLL who have received at least two lines of therapy, including a BTK inhibitor and a BCL-2 inhibitor, achieved an overall response rate of 72%.

Jaypirca is the first FDA-approved non-covalent (reversible) BTK inhibitor. It is a highly selective kinase inhibitor that can extend the benefit of targeting the BTK pathway in CLL/SLL patients due to a novel binding mechanism.

This is the marketing authorisation approval for the drug in 2023, after it was accelerated approval by the FDA for the treatment of mantle cell lymphoma (MCL) in January.

“Once patients with CLL or SLL have progressed on covalent BTK inhibitor and BCL-2 inhibitor therapies, treatments are limited and outcomes can be poor, making the approval of Jaypirca a meaningful advance and much-needed new treatment option for these patients,” said William Wierda, Professor, Medical Director, and CLL section head for the Department of Leukaemia at The University of Texas MD Anderson Cancer Center.

“Jaypirca offers a new treatment option and different approach to targeting BTK, providing clinical benefit for a high proportion of patients with CLL or SLL in the BRUIN Phase I/II trial whose disease progressed following treatment with a covalent BTK inhibitor and with a BCL-2 inhibitor.”

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