Pirtobrutinib gets FDA approval for relapsed or refractory mantle cell lymphoma

February 2023 Pharma News Willem van Altena

The American medicine authority FDA granted accelerated approval to pirtobrutinib for adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a BTK inhibitor. Pirtobrutinib is marketed by Eli Lilly under the brand name Jaypirca.

According to Eli Lilly, pirtobrutinib is the first non-covalent, or reversible, BTK inhibitor cleared in the US, as well as the first BTK inhibitor of any kind specifically okayed for MCL patients previously treated with a covalent BTK inhibitor.

The FDA based its approval on data from a subset of 120 MCL patients in the Phase I/II BRUIN study who received pirtobrutinib once daily until disease progression or unacceptable toxicity. Patients had been treated with a median of three prior lines of therapy, and all had received at least one prior line of therapy containing a covalent BTK inhibitor such as ibrutinib, acalabrutinib or zanubrutinib. The FDA noted that 83% of the participants had stopped their last BTK inhibitor due to refractory or progressive disease.

The overall response rate with pirtobrutinib was 50%, including 13% of patients who were in complete response. The median duration of response (DOR) in this analysis was 8.3 months, while the estimated DOR rate at six months was 65.3%. The drug’s prescribing information includes warnings and precautions for infections, haemorrhage, cytopenias, atrial fibrillation and flutter, and second primary malignancies.


Press release by the FDA regarding approval of pirtobrutinib.