Jaypirca FDA Approval History
Last updated by Judith Stewart, BPharm on Dec 18, 2023.
FDA Approved: Yes (First approved January 27, 2023)
Brand name: Jaypirca
Generic name: pirtobrutinib
Dosage form: Tablets
Company: Eli Lilly and Company
Treatment for: Mantle Cell Lymphoma, Chronic Lymphocytic Leukemia
Jaypirca (pirtobrutinib) is a non-covalent (reversible) Bruton's tyrosine kinase (BTK) inhibitor for use in the treatment of mantle cell lymphoma (MCL), and chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL).
- Jaypirca is indicated for the treatment of:
- adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a BTK inhibitor.
This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
- adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have received at least two prior lines of therapy, including a BTK inhibitor and a BCL-2 inhibitor.
This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. - Jaypirca works by binding to BTK to inhibit the activity of BTK kinase (a molecular target found across numerous B-cell leukemias) to block the activity that leads to growth of B-cells, and causes cell death of the malignant B-cells.
- Jaypirca is the first FDA-approved non-covalent (reversible) BTK inhibitor. It can re-establish BTK inhibition in patients previously treated with a covalent BTK inhibitor (ibrutinib, acalabrutinib, or zanubrutinib) and extend the benefit of targeting the BTK pathway.
- Jaypirca tablets are administered orally once daily until disease progression or unacceptable toxicity.
- Warnings and precautions associated with Jaypirca include infections, hemorrhage, cytopenias, cardiac arrythmias, second primary malignancies, and fetal harm.
- Common adverse reactions include fatigue, musculoskeletal pain, diarrhea, COVID-19, bruising, and cough. Common laboratory abnormalities include decreased neutrophil count, decreased platelet count, decreased hemoglobin, and decreased lymphocyte count.
Development timeline for Jaypirca
Further information
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