卢比替定 lurbinectedin

Drug Class

Alkylating agent / RNA polymerase II inhibitor

Mechanism

Binds to guanine residues in the DNA minor groove, causing DNA double-strand breaks, inhibiting active transcription by stalling RNA polymerase II, and degrading the enzyme to induce tumor cell apoptosis.

Approved Indication

Treatment of adult patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy.

What This Means For Patients

Lurbinectedin (Zepzelca) is a targeted alkylating agent approved by the FDA and NMPA (under the brand name Zanbijia) for patients with metastatic small cell lung cancer who have progressed on platinum-based chemotherapy. By binding to DNA and blocking transcription, it hinders tumor growth. Under special import guidelines, eligible patients can access this treatment in the Boao Lecheng pilot zone.

Regulatory Approvals

• FDA — approved (2020) — label
• NMPA — approved (2024) — source

Pivotal Clinical Evidence

• Study B-005 — Trigo et al., Lancet Oncol 2020 (NCT02454972) — DOI

Sources

• https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213756s000lbl.pdf
• https://www.nmpa.gov.cn/