FDA expands Jaypirca approval to certain previously untreated CLL and SLL patients

The U.S. Food and Drug Administration has expanded the indication for Eli Lilly’s Jaypirca, also known as pirtobrutinib, to include certain adults with previously untreated chronic lymphocytic leukemia or small lymphocytic lymphoma.

The new approval allows Jaypirca to be used as a first line treatment in adults with CLL or SLL who do not have a known 17p deletion.

Jaypirca is the first and only FDA approved non covalent Bruton tyrosine kinase inhibitor and is designed to selectively target the BTK pathway through a non covalent binding mechanism.

The latest decision is based on findings from the Phase III BRUIN CLL 313 study, which evaluated pirtobrutinib against bendamustine plus rituximab in previously untreated patients with CLL or SLL without 17p deletion.

At a median follow up of 28 months, Jaypirca significantly improved progression free survival compared with bendamustine plus rituximab.

Median progression free survival had not yet been reached in the pirtobrutinib group, compared with 33.5 months in the comparator arm.

The hazard ratio was 0.20, with a 95% confidence interval of 0.11 to 0.37 and a p value below 0.0001.

The overall response rate assessed by an independent review committee was 94% with Jaypirca compared with 81% for bendamustine plus rituximab.

Complete responses were reported in 13% of patients receiving pirtobrutinib and 21% of those in the comparator group, while partial responses were seen in 81% and 60% respectively.

Jennifer A. Woyach, MD, Professor and Director of the Division of Hematology at The Ohio State University Comprehensive Cancer Center, said the findings support the use of pirtobrutinib earlier in the treatment pathway.

She noted that many people with CLL or SLL may receive only one or two lines of therapy during their lifetime, making the initial treatment choice especially important.

The overall safety profile in BRUIN CLL 313 was consistent with previous studies of Jaypirca.

Adverse reactions led to dose reductions in 3.6% of patients and permanent treatment discontinuation in 4.3%.

Serious adverse reactions occurred in 28% of patients receiving Jaypirca, with pneumonia reported in 5%.

Rates of atrial fibrillation and flutter were also consistent with those observed in earlier pirtobrutinib studies.

Jacob Van Naarden, Executive Vice President and President of Lilly Oncology, said the expanded approval broadens the role of Jaypirca across the CLL treatment pathway.

He said the medicine can now be considered both as an initial treatment for appropriate patients and in relapsed or refractory disease after previous treatment with a covalent BTK inhibitor.

Jaypirca is also recommended in National Comprehensive Cancer Network guidelines.

It is listed as a Category 2A option for treatment naive adults with CLL or SLL without 17p deletion and as a Category 1 preferred option for adults with relapsed or refractory disease previously treated with a covalent BTK inhibitor.

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BTKinhibitor, clinical trials, CLL, Eli Lilly, FDA Approval, haemotology, jaypirca, leukemia, Lilly, lymphoma, Oncology, pharma news, pirtobrutinib, SLL