Difference between revisions of "Pralsetinib (Gavreto)"
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*2020-12-01: 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>)'' | *2020-12-01: 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>)'' | ||
*2020-12-01: 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>)'' | *2020-12-01: 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>)'' | ||
| + | *2023-08-09: Granted regular approval for adult patients with metastatic rearranged during transfection (RET) fusion-positive [[non-small cell lung cancer|non-small cell lung cancer (NSCLC)]] as detected by an FDA-approved test. ''(Based on ARROW<sub>RET</sub>)'' | ||
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==History of changes in EMA indication== | ==History of changes in EMA indication== | ||
*2021-11-18: Initial conditional authorization | *2021-11-18: Initial conditional authorization | ||
Revision as of 13:47, 10 August 2023
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
- 2020-09-04: Accelerated approval for adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC). (Based on ARROWRET)
- 2020-12-01: 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)
- 2020-12-01: 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)
- 2023-08-09: Granted regular approval for adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA-approved test. (Based on ARROWRET)
History of changes in EMA indication
- 2021-11-18: Initial conditional authorization
History of changes in Health Canada indication
- 2021-06-30: Initial notice of compliance with conditions for the treatment of adult patients with rearranged during transfection (RET) fusion-positive locally advanced unresectable or metastatic non-small cell lung cancer (NSCLC)
Also known as
- Code name: BLU-667
- Brand name: Gavreto