John Theurer Cancer Center Expert Shares Significance of Pirtobrutinib FDA Approval for Mantle Cell Lymphoma

Specialist offers insight on first reversible BTK inhibitor treatment for MCL 

In January, the FDA approved pirtobrutinib, a noncovalent reversible BTK inhibitor, in patients with Mantle Cell Lymphoma (MCL) previously treated with a BTK inhibitor. Lori A. Leslie, M.D., assistant professor, Hackensack Meridian School of Medicine, director, Indolent Lymphoma and Chronic Lymphocytic Leukemia Research Programs, John Theurer Cancer Center, recently joined the OncLive podcast to discuss the clinical significance of the drug’s FDA approval. Key points include:

• Pirtobrutinib is the first non-covalent BTK inhibitor for patients with relapsed or refractory MCL, opening a new treatment line for patients with historically poor outcomes after discontinuing treatment with a covalent BTK inhibitor.
• As a noncovalent BTK inhibitor, pirtobrutinib may work differently and could be transformative for many patients. Data from the Phase 1/2 BRUIN trial show a response rate of 51% in patients receiving prior BTK treatments.
• While the toxicity of various BTK inhibitors has not been compared head-to-head, pirtobrutinib cardiac side effects such as atrial fibrillation are relatively low, offering hope that this new treatment will be well tolerated.
• The current body of BTK inhibitor research is trending toward frontline treatment for patients with high-risk disease, including MCL patients with P53 abnormalities.

The FDA approval decision was based on the phase 1/2 BRUIN trial results. In this trial, the agent led to an objective response rate of 51% in BTK-pretreated patients and 82% in BTK-naïve patients not treated with BTK.

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