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Gavreto
Published
Product name
Gavreto
Active ingredient
Pralsetinib
Submission type
New Chemical Entity
Decision
Approved for provisional registration
Decision date
Registration date
What this medicine was approved for
Gavreto (pralsetinib) was approved for the following therapeutic use:
The provisionally approved new indication for the medicine is:
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.
How this medicine works
Pralsetinib is a tyrosine kinase inhibitor that targets oncogenic rearranged during transfection (RET) fusions and mutations, including V804 gatekeeper mutations associated with resistance to other therapies. In vitro, pralsetinib inhibited several oncogenic RET fusions and mutations (CCDC6 RET, RET V804L, RET V804M and RET M918T) with half maximal inhibitory concentrations at clinically relevant concentrations. In a broad panel of purified enzyme assays, pralsetinib demonstrated the highest selectivity for RET.
RET fusion proteins and activating point mutations can drive tumorigenic potential through hyperactivation of downstream signalling pathways leading to uncontrolled cell proliferation. Pralsetinib exhibited anti-tumour activity in cultured cells and animal tumour implantation models representing multiple tumour types harbouring oncogenic RET fusions or mutations (KIF5B-RET, CCDC6-RET, RET M918T, RET C634W, as well as the V804L and V804M mutants associated with cabozantinib and vandetanib resistance).
Why the TGA approved or did not approve this medicine
The decision was based on quality (chemistry and manufacturing), nonclinical (pharmacology and toxicology), clinical (pharmacology, safety and efficacy) and risk management plan information submitted by the sponsor. The benefit-risk profile of Gavreto was considered favourable for the therapeutic use approved.
Sponsor
ARTG details
- 380812