Lilly gets approval for earlier use of Jaypirca in CLL

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Two bottles of Jaypirca

Eli Lilly's fast-growing blood cancer drug Jaypirca has bagged a new FDA approval as an earlier treatment for relapsed or refractory chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL).

Reversible BTK inhibitor Jaypirca (pirtobrutinib) can now be used second-line, after prior treatment with a covalent (non-reversible) BTK inhibitor such as AbbVie/Johnson & Johnson's Imbruvica (ibrutinib), AstraZeneca's Calquence (acalabrutinib), and BeiGene's Brukinsa (zanubrutinib).

Previously, Lilly's drug was cleared as a third-line or later therapy for CLL after patients had already been treated with a BTK inhibitor and a BCL-2 inhibitor, i.e., AbbVie's Venclexta (venetoclax).

Jaypirca has been specifically designed to work in patients who develop 'escape' resistance mutations to covalent BTK inhibitors, and that profile has helped the drug make strong headway in the market, with sales rising 76% to $143 million.

The new approval comes on the back of the BRUIN CLL-321 study, which serves the twin objectives of extending Jaypirca's label and converting its earlier accelerated approval in later-line therapy into a full license.

At last year's ASH meeting, Lilly reported that Jaypirca achieved a significant improvement in progression-free survival (PFS) compared to the investigator's choice of Gilead's Zydelig plus rituximab or rituximab plus bendamustine, reducing the risk by 46%, although that did not translate to an improvement in overall survival (OS).

"Pirtobrutinib is the only medicine in CLL or SLL that has been prospectively studied in a randomised trial of patients previously treated with a covalent BTK inhibitor, and I am excited to see this expanded FDA approval recognise the benefit it can deliver to this broader group of patients," commented Jeff Sharman, of Willamette Valley Cancer Institute and Research Center, one of the principal investigators of the trial.

"When covalent BTK inhibitors are no longer an option due to disease progression or intolerance, pirtobrutinib enables physicians to extend the benefits of targeting the BTK pathway, offering continuity in the CLL or SLL treatment experience."

First-line the next prize

While the new approval strengthens Jaypirca's credentials in relapsed and refractory CLL and SLL, Lilly also has aspirations to move the drug even further up the treatment pathway into the first-line setting.

At this year's ASH, it is scheduled to report full data from the previously teased BRUIN CLL-313 trial, which found a significant improvement in PFS for Jaypirca compared to standard chemoimmunotherapy (CIT) in previously untreated CLL and SLL patients without 17p deletions.

The company previously reported the results of the BRUIN CLL-314 trial – which found that Jaypirca was as effective as Imbruvica in first-line CLL/SLL treatment – and has said it intends to combine the two trials as part of a regulatory filing to expand the label for Jaypirca before the end of this year.

Market research firm GlobalData has previously predicted that Jaypirca will become the market leader among BTK inhibitors for CLL, taking a nearly 60% share of the seven largest pharma markets in the US, Europe, and Japan in 2032, with sales of approximately $3 billion.