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Pirtobrutinib granted FDA approval for the treatment of R/R MCL

Jan 30, 2023
Learning objective: After reading this article, learners will be able to cite a new clinical development in mantle cell lymphoma.

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On January 27, 2023, it was announced that the U.S. Food and Drug Administration (FDA) had granted approval to pirtobrutinib, a non-covalent Bruton’s tyrosine kinase (BTK) inhibitor, for the treatment of adult patients with relapsed/refractory mantle cell lymphoma (MCL) after ≥2 prior lines of systemic therapy, including a previous BTK inhibitor.1

Pirtobrutinib was granted approval under the FDA's Accelerated Approval pathway based on key data from the phase I/II BRUIN trial (NCT03740529). Data was obtained from a subset of 120 patients with MCL, treated with pirtobrutinib 200 mg once daily until disease progression or unacceptable toxicity. The key efficacy outcomes were:

  • 50% overall response rate
  • 13% complete response rate
  • 38% partial response rate
  • median time to response of 1.8 months
  • median duration of response of 8.3 months

Serious adverse reactions occurred in 38% of patients. The most commonly reported serious adverse reactions were:

  • pneumonia (14%)
  • COVID-19 (4.7%)
  • musculoskeletal pain (3.9%)
  • hemorrhage (2.3%)
  • pleural effusion (2.3%)
  • sepsis (2.3%)

The approval of pirtobrutinib provides a new treatment option for patients with relapsed/refractory MCL, including those who have received prior covalent BTK inhibitors.

  1. S. 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. Published Jan 27, 2023. Accessed Jan 30, 2023.

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