FDA Approval Insights: Pirtobrutinib in MCL

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

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, we had the pleasure of speaking with Lori A. Leslie, MD, assistant professor, Hackensack Meridian School of Medicine, director, Indolent Lymphoma and Chronic Lymphocytic Leukemia Research Programs, John Theurer Cancer Center, about the FDA approval of pirtobrutinib (Jaypirca) in mantle cell lymphoma (MCL).

On January 27, 2023, the FDA approved pirtobrutinib, a noncovalent reversible BTK inhibitor, in patients with MCL previously treated with a BTK inhibitor. The regulatory decision was based on findings from the phase 1/2 BRUIN trial (NCT03740529), in which the agent led to an objective response rate of 51% (95% CI, 41%-61%) in BTK-pretreated patients and 82% (95% CI, 48%-98%) in BTK-naïve patients.

In our exclusive interview, Dr Leslie discussed the significance of this approval, key efficacy and safety findings from BRUIN, and potential treatment sequencing strategies in patients with resistance to covalent BTK inhibitors.

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