劳拉替尼 lorlatinib

Drug Class

Third-generation ALK tyrosine kinase inhibitor

Mechanism

Inhibits ALK and ROS1 tyrosine kinases, designed to cross the blood-brain barrier and overcome resistance mutations that develop during treatment with first- and second-generation ALK inhibitors.

Approved Indication

Treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive.

What This Means For Patients

Lorlatinib (Lorbrena/Lorviqua) is a third-generation targeted ALK inhibitor approved by the FDA, EMA, and NMPA for ALK-positive non-small cell lung cancer. It is designed to penetrate the central nervous system, helping to prevent or treat brain metastases. Under special import pathways, patients can access this treatment in the Boao Lecheng pilot zone.

Regulatory Approvals

• FDA — approved (2018) — label
• EMA — approved (2019) — source
• NMPA — approved (2022) — source

Pivotal Clinical Evidence

• CROWN — Shaw et al., N Engl J Med 2020 (NCT03052608) — DOI

Sources

• https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210868s003lbl.pdf
• https://www.ema.europa.eu/en/medicines/human/EPAR/lorviqua
• https://www.nmpa.gov.cn/