ZEPZELCA (Specialised Therapeutics Pharma Pty Ltd)
Product name
ZEPZELCA
Date registered
Evaluation commenced
Decision date
Approval time
153 (255 working days)
Active ingredients
lurbinectedin
Registration type
NCE/NBE
Indication
ZEPZELCA (powder for injection) is indicated for the treatment of patients with metastatic small cell lung cancer (SCLC) that has progressed on or after prior platinum-containing therapy. This indication was approved via the provisional approval pathway, based on objective response rate and duration of response in a single arm trial. Continued approval for this indication depends on verification and description of clinical benefit in a confirmatory trial.
Registration process
Provisional registration
Involves early access to vital and life-saving medicines through time-limited registration
Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.