GAVRETO (Roche Products Pty Ltd)
Product name
GAVRETO
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
242 (255 working days)
Active ingredients
pralsetinib
Registration type
NCE/NBE
Indication
Non-Small Cell Lung Cancer (NSCLC)
Gavreto has provisional approval in Australia for the treatment of adult patients with locally advanced or metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC). The decision to approve this indication has been made on the basis of overall response rate (ORR) and duration of response (DOR) in single-arm trials. Continued approval of this indication depends on verification and description of benefit in confirmatory trials.
Registration process
Provisional registration
Involves early access to vital and life-saving medicines through time-limited registration