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 is not distributed through mainland China's retail pharmacy network. Uwell Cloud can help arrange a purchase channel for this medicine, sourced and dispatched from Hong Kong; clinical administration support in China can be coordinated on request. Availability and eligibility for any specific patient are determined by clinical review.

Regulatory Approvals

• FDA — Approved (2023) — Sources
• EMA — Approved (2023) — Sources
• NMPA — Approved (2024) — Sources

Pivotal Clinical Evidence

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

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/