Pralsetinib (Gavreto)
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Mechanism of action
From the NCI Drug Dictionary: An orally bioavailable selective inhibitor of mutant forms of and fusion products involving the proto-oncogene receptor tyrosine kinase RET, with potential antineoplastic activity. Upon administration, BLU-667 binds to and targets various RET mutants and RET-containing fusion product.
Diseases for which it is used
History of changes in FDA indication
- 9/4/2020: Accelerated approval for adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC). (Based on ARROWRET)
- 12/1/2020: Accelerated approval for adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic therapy. (Based on ARROWRET)
- 12/1/2020: Accelerated approval for adult and pediatric patients 12 years of age and older with RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate). (Based on ARROWRET)
History of changes in EMA indication
- 11/18/2021: Initial conditional authorization
Also known as
- Code name: BLU-667
- Brand name: Gavreto