The U.S. Food and Drug Administration has approved pirtobrutinib (Jaypirca) for certain adults with previously untreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

The October 2 approval expands the use of the Eli Lilly drug to patients with no known 17p deletion, allowing it to be used as an initial treatment for eligible patients. Pirtobrutinib is a non-covalent Bruton tyrosine kinase (BTK) inhibitor taken orally.

The decision was based on the BRUIN CLL-313 Phase 3 trial, which included 282 previously untreated patients. After an estimated 28-month follow-up, the median progression-free survival had not been reached in the pirtobrutinib group, compared with 33.5 months for patients receiving bendamustine plus rituximab.

The FDA lists potential risks including infections, bleeding, reduced blood cell counts, cardiac arrhythmias, secondary cancers and liver toxicity. The recommended dose for this indication is 200 mg once daily until disease progression or unacceptable toxicity.

The approval adds a new targeted-treatment option for a defined group of adults beginning treatment for these blood cancers and expands the role of pirtobrutinib beyond its previously approved uses.