Jaypirca pirtobrutinib

Drug Class

Non-covalent BTK inhibitor

Mechanism

Reversibly inhibits both wild-type and C481-mutant BTK to overcome covalent BTK inhibitor resistance.

Approved Indication

Treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a covalent BTK inhibitor; or relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least two lines of therapy, including a BTK inhibitor and a BCL-2 inhibitor.

What This Means For Patients

Jaypirca (pirtobrutinib) is a reversible BTK inhibitor designed to treat advanced mantle cell lymphoma and chronic lymphocytic leukemia. It works on a different binding mechanism to bypass resistance developed against first-generation inhibitors. It is available under the special-import policy in the Hainan Boao Lecheng pilot zone.

Regulatory Approvals

• FDA — approved (2023) — label
• EMA — approved (2023) — source
• NMPA — approved (2024) — source

Pivotal Clinical Evidence

• BRUIN — Mato et al., Lancet 2021 (NCT03740529) — DOI

Sources

• https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/216059s000lbl.pdf
• https://www.ema.europa.eu/en/medicines/human/EPAR/jaypirca
• https://www.nmpa.gov.cn/