WASHINGTON, October 12, 2026 — The U.S. Food and Drug Administration (FDA) has approved pirtobrutinib (Jaypirca®) for adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have not been treated before and do not have a known 17p deletion.
The FDA's decision was based on results from a clinical trial that compared pirtobrutinib with a chemotherapy-based treatment regimen called bendamustine plus rituximab. The study included 282 people with previously untreated CLL or SLL.
Researchers found that pirtobrutinib reduced the risk of disease progression or death by 80% compared with bendamustine plus rituximab. In addition, 94% of people receiving pirtobrutinib responded to treatment, compared with 81% of those receiving bendamustine plus rituximab.
This approval provides another treatment option for people with CLL or SLL who have not received prior treatment.
"When you're diagnosed with CLL, knowing there are multiple effective treatment options available can provide reassurance during a very uncertain time," said Lore Gruenbaum, Ph.D., chief scientific officer of Blood Cancer United. "Every patient's situation is different, so having another proven treatment available from the start gives patients and their doctors more flexibility to choose the treatment that's right for them."
Pirtobrutinib was first approved in January 2023 to treat adults with mantle cell lymphoma that had worsened or returned despite earlier treatment. Later that same year, the FDA approved pirtobrutinib for CLL/SLL as a third-line treatment option. This meant it could be given only after a patient had been treated with at least two previous therapies, including a BTK inhibitor and a BCL-2 inhibitor.
Funding the science behind a drug class, and beyond
Pirtobrutinib belongs to a class of drugs called BTK inhibitor, which have changed the treatment landscape for many types of blood cancer.
Blood Cancer United was at the forefront of funding research that advanced the understanding of the role of the BTK protein in the proliferation of several types of B-cell blood cancers.
Today, Blood Cancer United funds studies that aim to define how cancer cells become resistant to treatment, and studies to determine the best sequence for the use of BTK inhibitors.
Additionally, Blood Cancer United has dedicated research dollars to identify ways to combine BTK and BCL-2 inhibitors with other effective therapies to keep people in remission even longer.
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