FDA Approval Insights: Pirtobrutunib in Previously Treated CLL/SLL

Welcome to OncLive On Air^®! I’m your host today, Ashling Wahner.

OncLive On Air is a podcast from OncLive^®, which provides oncology professionals with the resources and information they need to provide the best patient care. In both digital and print formats, OncLive covers every angle of oncology practice, from new technology to treatment advances to important regulatory decisions.

In today’s episode, sponsored by Eli Lilly, we had the pleasure of speaking with Matthew S. Davids, MD, MMSc, about the FDA approval of pirtobrutinib (Jaypirca) for patients with previously treated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Dr Davids is director of Clinical Research and associate director of the CLL Center at Dana-Farber Cancer Institute, as well as an associate professor of medicine at Harvard Medical School, both in Boston, Massachusetts.

On December 1, 2023, the FDA granted accelerated approval to pirtobrutinib for the treatment of adult patients with CLL or SLL who have received 2 or more prior lines of therapy, including a BCL-2 inhibitor and a BTK inhibitor. This regulatory decision was supported by findings from the CLL/SLL cohort (n = 108) of the single-arm, phase 1/2 BRUIN trial (NCT03740529), in which the agent elicited an overall response rate of 72% (95% CI, 63%-80%), all of which were partial responses.

In our exclusive interview, Dr Davids discussed the significance of this approval; key efficacy and safety data from the BRUIN trial; and guidelines for pirtobrutinib use in clinical practice in the CLL/SLL patient population.

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