LUMAKRAS (Amgen Australia Pty Ltd)
Product name
LUMAKRAS
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
244 (255 working days)
Active ingredients
sotorasib
Registration type
NCE/NBE
Indication
LUMAKRAS (film-coated tablet) has provisional approval in Australia for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC) who have received at least one prior systemic therapy for advanced disease.
The decision to approve this indication has been made on the basis of the objective response rate (ORR) and the duration of response (DOR). Continued approval of this indication depends on the verification and description of benefit in confirmatory trials.
Registration process
Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.