Lilly’s Jaypirca Gains FDA Approval for First-Line CLL/SLL Treatment

Eli Lilly and Company has received approval from the US Food and Drug Administration (FDA) for an additional indication for Jaypirca (pirtobrutinib) in adults with previously untreated chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL) without a known 17p deletion. 

The approval enables Jaypirca to be used as a first-line treatment for appropriate patients.

Jaypirca is a non-covalent Bruton tyrosine kinase (BTK) inhibitor designed to block the BTK pathway. 

The approval is based on results from the Phase 3 BRUIN CLL-313 trial, which compared pirtobrutinib with bendamustine plus rituximab in previously untreated patients.

At a median follow-up of 28 months, pirtobrutinib significantly improved progression-free survival (PFS), reducing the risk of disease progression or death by 80% compared with the chemotherapy combination. 

Median PFS was not reached in the pirtobrutinib group, compared with 33.5 months for bendamustine plus rituximab.

The overall response rate was 94% with pirtobrutinib and 81% with the comparator treatment. 

The safety profile was consistent with previous studies of Jaypirca, with serious adverse reactions reported in 28% of patients.

The approval expands Jaypirca’s use across the CLL/SLL treatment pathway, including first-line treatment and relapsed or refractory disease following a covalent BTK inhibitor.

Source: https://investor.lilly.com