Difference between revisions of "Pralsetinib (Gavreto)"
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*12/1/2020: Accelerated approval for adult and pediatric patients 12 years of age and older with advanced or metastatic [[Biomarkers#RET|RET]]-[[Biomarkers#Alterations|mutant]] [[Thyroid cancer, medullary|medullary thyroid cancer]] (MTC) who require systemic therapy. ''(Based on ARROW<sub>RET</sub>)'' | *12/1/2020: Accelerated approval for adult and pediatric patients 12 years of age and older with advanced or metastatic [[Biomarkers#RET|RET]]-[[Biomarkers#Alterations|mutant]] [[Thyroid cancer, medullary|medullary thyroid cancer]] (MTC) who require systemic therapy. ''(Based on ARROW<sub>RET</sub>)'' | ||
*12/1/2020: Accelerated approval for adult and pediatric patients 12 years of age and older with [[Biomarkers#RET|RET]] [[Biomarkers#fusion|fusion-positive]] [[thyroid cancer]] who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate). ''(Based on ARROW<sub>RET</sub>)'' | *12/1/2020: Accelerated approval for adult and pediatric patients 12 years of age and older with [[Biomarkers#RET|RET]] [[Biomarkers#fusion|fusion-positive]] [[thyroid cancer]] who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate). ''(Based on ARROW<sub>RET</sub>)'' | ||
| − | + | ==History of changes in EMA indication== | |
| + | *11/18/2021: Initial conditional authorization | ||
==Also known as== | ==Also known as== | ||
*'''Code name:''' BLU-667 | *'''Code name:''' BLU-667 | ||
| Line 24: | Line 25: | ||
[[Category:Thyroid cancer medications]] | [[Category:Thyroid cancer medications]] | ||
| + | [[Category:EMA approved in 2021]] | ||
[[Category:FDA approved in 2020]] | [[Category:FDA approved in 2020]] | ||
Revision as of 02:32, 31 December 2022
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