The U.S. Food and Drug Administration (FDA) has expanded its approval of pirtobrutinib (Jaypirca). Pirtobrutinib may now be used to treat chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) in people with no known 17p deletion who haven’t received treatment yet.

Pirtobrutinib is an oral targeted cancer treatment that was previously approved for certain adults with CLL/SLL who had already received treatment. The expanded approval makes pirtobrutinib available as a first-line treatment, meaning it can be used as the first treatment when someone is ready to start therapy for CLL/SLL.

The expanded approval gives some people with CLL/SLL another targeted treatment option to discuss with their oncology team.

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What Did Clinical Trials Show?

The FDA based its approval on the results of BRUIN CLL-313, a phase 3 clinical trial involving 282 adults with previously untreated CLL/SLL who had no known 17p deletion.

Participants received either pirtobrutinib or bendamustine plus rituximab, a combination of chemotherapy and immunotherapy that’s currently a standard first-line therapy for CLL/SLL.

Lower Relative Risk of Progression or Death

After about 28 months of follow-up, people taking pirtobrutinib had an approximately 80 percent lower relative risk of dying or of their cancer getting worse compared with those receiving bendamustine plus rituximab.

This was a relative reduction in risk, not an 80-percentage-point difference in the number of people whose cancer progressed.

Improvement in Progression-Free Survival

Researchers also measured progression-free survival, which means the length of time people lived without their cancer getting worse.

At 24 months, the progression-free survival rates were:

• 93.4 percent for people taking pirtobrutinib
• 70.7 percent for people receiving bendamustine plus rituximab

At the time researchers analyzed the results, more than half of the people taking pirtobrutinib had not experienced disease progression. In the bendamustine-plus-rituximab group, the median time without progression was 33.5 months.

Researchers need more time to determine whether pirtobrutinib helps people live longer than the comparison treatment.

The study compared pirtobrutinib with bendamustine plus rituximab, not with other BTK inhibitors or newer targeted treatments. More research is needed to understand how these options compare.

Why Does This Approval Matter for People With CLL/SLL?

The FDA previously approved pirtobrutinib for adults with CLL/SLL whose cancer had returned or stopped responding to treatment after they received a covalent BTK inhibitor. The new approval expands its use to an earlier stage of treatment for a specific group of adults.

If you haven’t started treating CLL/SLL yet or if your current treatment isn’t meeting your needs, talk with your healthcare team about what other options may be available. Together, you can explore treatments that fit your health needs and personal goals.