Difference between revisions of "Selpercatinib (Retevmo)"
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*5/8/2020: Granted accelerated approval for adult and pediatric patients ≥12 years of age with advanced or metastatic [[Biomarkers#RET|RET]]-[[Biomarkers#Alterations|mutant]] medullary [[thyroid cancer]] (MTC) who require systemic therapy. ''(Based on LIBRETTO-001)'' | *5/8/2020: Granted accelerated approval for adult and pediatric patients ≥12 years of age with advanced or metastatic [[Biomarkers#RET|RET]]-[[Biomarkers#Alterations|mutant]] medullary [[thyroid cancer]] (MTC) who require systemic therapy. ''(Based on LIBRETTO-001)'' | ||
*5/8/2020: Granted accelerated approval for adult and pediatric patients ≥12 years of age with advanced or metastatic [[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 LIBRETTO-001)'' | *5/8/2020: Granted accelerated approval for adult and pediatric patients ≥12 years of age with advanced or metastatic [[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 LIBRETTO-001)'' | ||
+ | |||
+ | ==History of changes in EMA indication== | ||
+ | *2/11/2021: Initial marketing authorization as Retsevmo. | ||
==Also known as== | ==Also known as== | ||
*'''Code name:''' LOXO-292 | *'''Code name:''' LOXO-292 | ||
− | *'''Brand | + | *'''Brand names:''' Retevmo, Retsevmo |
[[Category:Drugs]] | [[Category:Drugs]] | ||
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[[Category:Non-small cell lung cancer medications]] | [[Category:Non-small cell lung cancer medications]] | ||
[[Category:Thyroid cancer medications]] | [[Category:Thyroid cancer medications]] | ||
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+ | [[Category:EMA approved in 2021]] | ||
[[Category:FDA approved in 2020]] | [[Category:FDA approved in 2020]] |
Revision as of 03:25, 5 December 2021
Mechanism of action
From the NCI Drug Dictionary: An orally bioavailable selective inhibitor of wild-type, mutant and fusion products involving the proto-oncogene receptor tyrosine kinase rearranged during transfection (RET), with potential antineoplastic activity. Upon oral administration, LOXO-292 selectively binds to and targets various RET mutants and RET-containing fusion products. This results in an inhibition of cell growth of tumors cells that exhibit increased RET activity.
Diseases for which it is used
- RET-positive NSCLC
- RET-mutant medullary thyroid cancer
- RET-positive thyroid cancer
History of changes in FDA indication
Non-small cell lung cancer
- 5/8/2020: Granted accelerated approval for adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC). (Based on LIBRETTO-001)
Thyroid cancer
- 5/8/2020: Granted accelerated approval for adult and pediatric patients ≥12 years of age with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic therapy. (Based on LIBRETTO-001)
- 5/8/2020: Granted accelerated approval for adult and pediatric patients ≥12 years of age with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate). (Based on LIBRETTO-001)
History of changes in EMA indication
- 2/11/2021: Initial marketing authorization as Retsevmo.
Also known as
- Code name: LOXO-292
- Brand names: Retevmo, Retsevmo