FDA approves Jaypirca for advanced mantle cell lymphoma
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The FDA granted accelerated approval to pirtobrutinib for treatment of certain patients with advanced mantle cell lymphoma.
The indication applies to use of the agent by adults with relapsed or refractory disease who received at least two lines of systemic therapy, including a Bruton tyrosine kinase (BTK) inhibitor.
Pirtobrutinib (Jaypirca, Eli Lilly) is a selective, noncovalent inhibitor of BTK.
The FDA based the approval on results of the phase 1/phase 2 BRUIN trial, which included 120 patients with relapsed or refractory mantle cell lymphoma who had received a covalent BTK inhibitor. Patients had received a median three (range, 1-9) prior therapies.
Study participants received 200 mg pirtobrutinib once-daily until disease progression or unacceptable toxicity.
Researchers reported a 50% overall response rate and a 13% complete response rate.
A safety analysis included 128 patients with mantle cell lymphoma, of whom 4.7% required dose reductions, 32% required treatment interruption and 9% discontinued treatment due to adverse reactions.
More than one-third (38%) of patients experienced serious adverse reactions, the most common of which included pneumonia (14%), COVID-19 (4.7%), musculoskeletal pain (3.9%), hemorrhage (2.3%), pleural effusion (2.3%) and sepsis (2.3%).
Continued approval may be contingent upon verification of benefit in a confirmatory trial. Enrollment for a confirmatory phase 3 trial is underway.
"The approval of Jaypirca represents an important advance for patients with relapsed or refractory [mantle cell lymphoma], who currently have limited options and historically have had a poor prognosis following discontinuation of treatment with a covalent BTK inhibitor," Michael Wang, MD, Puddin Clarke endowed professor of lymphoma and myeloma at The University of Texas MD Anderson Cancer Center, said in a press release. "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. 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 [patients with relapsed and refractory mantle cell lymphoma].”
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