Product Dossier
ZEPZELCA
Product Dossier for ZEPZELCA (lurbinectedin, Specialised Therapeutics Pharma). ARTG record, PBS listing, PBAC outcomes, AusPAR — compiled by arcimedes.
- Sponsor: Specialised Therapeutics Pharma
- Active ingredient: lurbinectedin
- Therapeutic area: Oncology
- Same area: TALZENNA
- Same area: ZARZIO
What it is
ZEPZELCA is lurbinectedin 4 mg powder for solution for infusion.
Approved indications
— Treatment of patients with metastatic small cell lung cancer (SCLC) that has progressed on or after prior platinum-containing therapy.
Key safety warnings
ZEPZELCA was provisionally approved based on objective response rate and duration of response data from a single-arm trial, with continued approval contingent on verification of clinical benefit in a confirmatory trial.
Regulatory history
ZEPZELCA received TGA approval on 2021-09-10 for the treatment of patients with metastatic small cell lung cancer (SCLC) that has progressed on or after prior platinum-containing therapy. The TGA approved Zepzelca for provisional registration. ZEPZELCA was first listed on the ARTG on 2021-09-13.