The US Food and Drug Administration (FDA) has granted accelerated approval to Jaypirca™ (pirtobrutinib) for the treatment of adults with relapsed or refractory mantle cell lymphoma (MCL) after at least 2 lines of systemic therapy, including a BTK inhibitor.

As a noncovalent inhibitor of BTK, pirtobrutinib is able to reestablish BTK inhibition in patients previously treated with covalent BTK inhibitors (eg, acalabrutinib, ibrutinib, zanubrutinib). This allows for continued targeting of the BTK pathway.

The accelerated approval of pirtobrutinib was based on data from the phase 1/2 BRUIN trial ( Identifier: NCT03740529), an open-label, single-arm study that included 120 patients with MCL who were previously treated with a BTK inhibitor. Study participants received pirtobrutinib at 200 mg once daily until disease progression or unacceptable toxicity. 

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The overall response rate was 50%, which included a complete response rate of 13% and a partial response rate of 38%. The median time to response was 1.8 months, and the median duration of response was 8.3 months.

The most common adverse reactions were fatigue, musculoskeletal pain, diarrhea, edema, dyspnea, pneumonia, and bruising. Grade 3 or 4 laboratory abnormalities included decreased neutrophil count, decreased lymphocyte count, and decreased platelet count.

“These data indicate that Jaypirca can provide efficacy in patients previously treated with a covalent BTK inhibitor, potentially extending the time patients may benefit from BTK inhibition therapy,” said Michael Wang, MD, of the University of Texas MD Anderson Cancer Center in Houston. “Jaypirca offers a new approach to targeting the BTK pathway following treatment with a covalent BTK inhibitor and has the potential to meaningfully impact the treatment paradigm for relapsed and refractory MCL patients.”

In a press statement, Lilly announced that a confirmatory phase 3 trial (BRUIN MCL-321; Identifier: NCT04662255), which will compare pirtobrutinib to other FDA-approved BTK inhibitors, is currently enrolling patients.

Jaypirca is supplied as 50 mg and 100 mg tablets. It is expected to be available in the coming weeks.


US FDA approves Jaypirca™ (pirtobrutinib), the first and only non-covalent (reversible) BTK inhibitor, for adult patients with relapsed or refractory mantle cell lymphoma after at least two lines of systemic therapy, including a BTK inhibitor. News release. January 27, 2023.

Jaypirca. Package insert. Eli Lilly; 2023. Accessed January 27, 2023.

This article originally appeared on MPR