Policy & Regulation
Loxo@Lilly's Jaypirca receives US FDA approval
30 January 2023 -

Loxo@Lilly, the oncology unit of US-based Eli Lilly and Company (NYSE: LLY), announced on Friday that the company has received approval for Jaypirca (pirtobrutinib, 100mg & 50mg tablets) from the US Food and Drug Administration.

The product is intended to treat adult patients with relapsed or refractory mantle cell lymphoma (MCL) after around two lines of systemic therapy, including a Bruton's tyrosine kinase (BTK) inhibitor. It received approval under the FDA's Accelerated Approval pathway based on response rate from the open-label, single-arm, international, Phase one/two study, called the BRUIN trial. Jaypirca received approval based on data from a subset of patients in the BRUIN Phase one/two trial.

Jaypirca is a highly selective kinase inhibitor that uses a novel binding mechanism and is the first and only FDA approved non-covalent (reversible) BTK inhibitor. It can re-establish BTK inhibition in MCL patients previously treated with a covalent BTK inhibitor (ibrutinib, acalabrutinib, or zanubrutinib) and extend the advantage of targeting the BTK pathway.