曲贝替定 trabectedin

Drug Class

Alkylating agent / DNA binder

Mechanism

Binds to the minor groove of DNA, bending the helix toward the major groove, interfering with transcription regulation and cell division pathways.

Approved Indication

FDA-approved for the treatment of patients with unresectable or metastatic liposarcoma or leiomyosarcoma who received a prior anthracycline-containing regimen.

What This Means For Patients

Trabectedin (brand name Yondelis) is an oncology alkylating agent targeting soft tissue sarcomas. It is approved by the FDA and EMA and accessible for clinical use in Hainan Boao Lecheng.

Regulatory Approvals

• FDA — approved (2015) — label
• EMA — approved (2007) — source

Pivotal Clinical Evidence

• ET743-SAR-3007 — Demetri et al., J Clin Oncol 2016 (NCT01343277) — DOI

Sources

• https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207953s000lbl.pdf
• https://www.ema.europa.eu/en/medicines/human/EPAR/yondelis