FDA approves pirtobrutinib for relapsed or refractory mantle cell lymphoma

The FDA granted accelerated approval to pirtobrutinib (Jaypirca) on January 27, 2023, for adults with relapsed or refractory mantle cell lymphoma after at least two lines of systemic therapy, including a BTK inhibitor.

Approval was based on BRUIN, an open-label trial that included 120 patients previously treated with a BTK inhibitor. The FDA reported an overall response rate of 50%, including a complete response rate of 13%. The estimated median duration of response was 8.3 months. Patients received pirtobrutinib orally at 200 mg once daily until their disease progressed or they had unacceptable toxicity. The most common adverse reactions were fatigue, musculoskeletal pain, diarrhea, edema, dyspnea, pneumonia, and bruising. The prescribing information includes warnings for infections, hemorrhage, cytopenias, atrial fibrillation and flutter, and second primary malignancies.