Curie Brief
Turn on cookies to sign in
Signing in saves your progress to your Curie account. We can only do that with cookies on — turn them on to continue.
News
Pirtobrutinib (Jaypirca) just got a bigger green light from the FDA. The agency expanded approval of the BTK inhibitor to cover first-line treatment of chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) in patients without a 17p deletion. A phase 3 trial showed an 80% reduction in the risk of progression or death compared to standard chemoimmunotherapy.
The FDA has expanded its approval of pirtobrutinib (Jaypirca, Eli Lilly) to include first-line treatment of adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who don't have a known 17p deletion. Previously, the drug was only approved for patients who had already tried a BTK inhibitor or for certain relapsed/refractory mantle cell lymphoma cases — so this marks a significant step forward in its clinical reach.
The approval is backed by the phase 3 BRUIN CLL-313 trial, which enrolled 282 previously untreated CLL/SLL patients. Those on pirtobrutinib saw dramatically better outcomes than those on the standard bendamustine-rituximab chemoimmunotherapy regimen, with median PFS not yet reached in the pirtobrutinib group after 28 months of follow-up.
By the Numbers:
Why it matters: Since many CLL/SLL patients today may only receive one or two lines of therapy — due to age or other health conditions — getting the first treatment right is critical. Expanding pirtobrutinib's use to the front line gives clinicians a powerful new targeted option right from the start.
