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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:
Serious adverse reactions occurred in 38% of patients. The most commonly reported serious adverse reactions were:
The approval of pirtobrutinib provides a new treatment option for patients with relapsed/refractory MCL, including those who have received prior covalent BTK inhibitors.
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