IMDELLTRA (Amgen Australia Pty Ltd)
Product name
IMDELLTRA
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
185 (255 working days)
Active ingredients
tarlatamab
Registration type
NCE/ NBE
Indication
Imdelltra has provisional approval in Australia for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy.
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.