ZEPZELCA (Specialised Therapeutics Pharma Pty Ltd)
Product name
ZEPZELCA
Date registered
Evaluation commenced
Decision date
Approval time
178 (255 working days)
Active ingredients
lurbinectedin
Registration type
EOI
Indication
ZEPZELCA, in combination with atezolizumab, is indicated for the maintenance treatment of extensive-stage small cell lung cancer (SCLC) in adult patients whose disease has not progressed after first-line induction therapy with atezolizumab, carboplatin and etoposide.
Registration process
Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.