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FDA approves pirtobrutinib for patients with relapsed/refractory CLL/SLL
By Sabina Ray
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On December 1, 2023, it was announced that the U.S. Food and Drug Administration (FDA) had approved pirtobrutinib, a selective non-covalent Bruton’s tyrosine kinase inhibitor (BTKi), for the treatment of adult patients with relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL) or small lymphocytic leukemia (SLL) after ≥2 lines of therapy, including a B-cell lymphoma 2 inhibitor and BTKi. This decision is based on promising overall response and duration of response rates from the phase I/II BRUIN (NCT03740529).1
BRUIN trial
BRUIN is a phase I/II open-label study evaluating pirtobrutinib in patients with R/R CLL/SLL.1 The Lymphoma Hub previously reported the trial design and promising results (Figure 1).
Figure 1. BRUIN trial outcomes in patients with R/R CLL/SLL (n = 108)*
ORR, overall response rate.
*Adapted from PR Newswire.1
Conclusion
The approval of pirtobrutinib provides patients with R/R CLL/SLL another treatment option that could potentially benefit their patient journey.
- PR Newswire. Jaypirca® (pirtobrutinib) now approved by U.S. FDA for the treatment of adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma who have rreceived at least two lines of therapy, including a BTK inhibitor and a BCL-2 inhibitor. https://www.prnewswire.com/news-releases/jaypirca-pirtobrutinib-now-approved-by-us-fda-for-the-treatment-of-adult-patients-with-chronic-lymphocytic-leukemia-or-small-lymphocytic-lymphoma-who-have-received-at-least-two-lines-of-therapy-including-a-btk-inhibitor-and--302003695.html. Published Dec 1, 2023. Accessed Dec 4, 2023.
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