GAVRETO (Roche Products Pty Ltd)
Product name
GAVRETO
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
247 (255 working days)
Active ingredients
pralsetinib
Registration type
NCE/NBE
Indication
RET-Fusion Positive Thyroid Cancer
Gavreto has provisional approval in Australia for the treatment of adult patients with advanced or metastatic RET-fusion positive thyroid cancer that is refractory to (or unsuitable for) radioactive iodine and who have progressed on or are unable to tolerate lenvatinib or sorafenib. The decision to approve this indication has been made on the basis of overall response rate (ORR) and duration of response (DOR). 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