Pirtobrutinib delayed progression for some adults with untreated CLL
In a 282-person trial, the cancer took longer to worsen than with a common chemoimmunotherapy. Survival is not proven, and the approval excludes a 17p deletion.
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On October 2, 2026, the FDA approved pirtobrutinib for adults with previously untreated chronic lymphocytic leukemia or small lymphocytic lymphoma who do not have a known deletion of chromosome 17p. The evidence is a randomized trial called BRUIN CLL-313. Of 282 adults, 141 took pirtobrutinib until the cancer grew or the drug became too hard to tolerate, and 141 received bendamustine plus rituximab for six cycles.
After about 28 months, independent reviewers found the cancer took longer to progress on pirtobrutinib. A typical time to progression could not yet be calculated for that group. In the comparison group it was 33.5 months. The hazard ratio was 0.20. Overall survival was not established. Thirteen people had died, three on pirtobrutinib and ten on the comparison treatment, and a median survival time had not been reached in either group. The most common side effects, each in at least a fifth of people on pirtobrutinib, were upper respiratory infections, rash, and COVID-19. Serious adverse reactions occurred in 28 percent. The label warns about infections, bleeding, low blood counts, heart rhythm problems, second cancers, liver injury, and harm during pregnancy. This is not a cure, and it does not apply to patients with a 17p deletion.
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