FDA Approves Jaypirca for Relapsed/Refractory Mantle Cell Lymphoma


The Food and Drug Administration approved Jaypirca for patients with relapsed/refractory mantle cell lymphoma who have been previously treated with multiple lines of therapy.

The Food and Drug Administration approved Jaypirca (pirtobrutinib) for the treatment of patients with relapsed/refractory mantle cell lymphoma who have previously undergone at least two lines of therapy, including a BTK inhibitor.

The approval was based on findings from the single-arm phase 1/2 BRUIN trial, which included 120 patients with mantle cell lymphoma who had previously been given a BTK inhibitor. On average, participants had three prior lines of therapy, with most (92%) having two or more. Most commonly, patients were previously treated with Calquence (acalabrutinib), and 83% stopped their previous regimen because their disease worsened.

Half (50%) of patients responded to treatment with Jaypirca, and 13% had a complete response, meaning that after treatment, there were no detectable traces of cancer. The average duration of response was 8.3 months, with 65.3% of patients still responding to treatment at the six-month mark.

“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 relapsed and refractory (mantle cell lymphoma) patients,” said Dr. Michael Wang, Puddin Clarke Endowed Professor of Lymphoma and Myeloma at The University of Texas MD Anderson Cancer Center in Houston, in a press release.

The most common side effects that occurred in 15% or more of patients in the BRUIN trial were fatigue, musculoskeletal pain, diarrhea, swelling, shortness of breath, pneumonia and bruising.

Moderate or severe laboratory abnormalities that occurred in 10% or more of patients were decreased neutrophil counts, lymphocyte counts and platelet counts. The prescribing information for Jaypirca includes warnings and precautions for infections, hemorrhage, cytopenias, atrial fibrillation (irregular, very rapid heart rhythms) and flutter and second primary malignancies.

"Until now, people living with (mantle cell lymphoma) who can no longer be treated with BTK inhibitors have had few alternatives," said Meghan Gutierrez, chief executive officer of the Lymphoma Research Foundation, in the release. "The approval of Jaypirca brings a new treatment option and, along with that, new hope for people with relapsed or refractory (mantle cell lymphoma)."

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