Pirtobrutinib received U.S. Food and Drug Administration (FDA) approval for the treatment of chronic lymphocytic leukemia (CLL) and small lymphocytic leukemia (SLL) in adult patients who have received at least two lines of prior therapy, including a Bruton tyrosine kinase (BTK) inhibitor and a BCL2 inhibitor.
A non-covalent, highly selective BTK inhibitor, pirtobrutinib uses a new binding mechanism to extend the benefit of targeting the BTK pathway in patients with CLL/SLL who have previously been treated with a covalent BTK inhibitor.
Approval was granted via the FDA accelerated approval pathway based on the results of the open-label, single-arm, multicohort, international, phase I/II BRUIN study. Specifically, the overall response rate and duration of response paved the way for this approval.
The trial also noted that the most common adverse reactions were pneumonia, diarrhea, nausea, edema, pyrexia, headache, fatigue, cough, bruising, dyspnea, musculoskeletal pain, abdominal pain, COVID-19, and hemorrhage.
“The treatment landscape for CLL has been dramatically improved by the introduction of covalent BTK inhibitors and BCL2 inhibitors. However, most patients will unfortunately relapse eventually,” said Brian Koffman, MD, chief medical officer and executive vice president at the CLL Society. “Pirtobrutinib’s approval gives patients a much-needed option and brings forward new possibilities as they continue their treatment journey.”
This is the second approved indication for pirtobrutinib, following the first approval of the medication for the treatment of relapsed or refractory mantle cell lymphoma after at least two lines of systemic therapy, including a BTK inhibitor in adult patients.
Sources: FDA, December 1, 2023. Lilly, December 1, 2023.
