Pirubrutinib is indicated for the following adult patients:
1) Mantle cell lymphoma (MCL) relapsed or refractory after at least two prior therapies (including a BTK inhibitor);
2) Chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have received at least two prior therapies, including a Bruton’s tyrosine kinase (BTK) inhibitor and a BCL-2 inhibitor. The National Medical Products Administration (NMPA) has approved pirtobrutinib as a monotherapy for adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have previously received a BTK inhibitor.
Pirtobrutinib Dosage and Administration:
200 mg orally once daily until disease progression or unacceptable toxicity. Recommendation: Swallow the tablet with water. Do not cut, crush, or chew the tablet. It may be taken with or without food. If a dose of pirtobrutinib is missed by more than 12 hours, do not miss the missed dose and take the next scheduled dose.
Clinical Data on Pirubrutinib:
In the Phase I/II BRUIN trial, the safety and efficacy of Pirubrutinib were evaluated in patients with mantle cell lymphoma. Among patients with mantle cell lymphoma who had previously received BTK inhibitors, the median age was 70 years and the median number of prior lines of therapy was three.
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