Difference between revisions of "Selpercatinib (Retevmo)"
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==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
===[[Non-small cell lung cancer]]=== | ===[[Non-small cell lung cancer]]=== | ||
| − | * | + | *2020-05-08: Granted accelerated approval for adult patients with metastatic [[Biomarkers#RET|RET]] [[Biomarkers#fusion|fusion-positive]] [[Non-small cell lung cancer|non-small cell lung cancer (NSCLC)]]. ''(Based on LIBRETTO-001)'' |
| − | * | + | *2022-09-21: Granted regular approval for adult patients with locally advanced or metastatic [[Non-small cell lung cancer|non-small cell lung cancer (NSCLC)]] with a [[Biomarkers#RET|rearranged during transfection (RET) gene]] [[Biomarkers#fusion|fusion]]. ''(Based on LIBRETTO-001)'' |
===[[RET|RET (tissue-agnostic)]]=== | ===[[RET|RET (tissue-agnostic)]]=== | ||
| − | * | + | *2022-09-21: Granted accelerated approval for adult patients with locally advanced or metastatic [[:Category:Malignant solid neoplasm|solid tumors]] with a [[Biomarkers#RET|rearranged during transfection (RET) gene]] [[Biomarkers#fusion|fusion]] that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options. ''(Based on LIBRETTO-001)'' |
===[[Thyroid cancer]]=== | ===[[Thyroid cancer]]=== | ||
| − | * | + | *2020-05-08: 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)'' |
| − | * | + | *2020-05-08: 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== | ==History of changes in EMA indication== | ||
| − | * | + | *2021-02-11: Initial conditional authorization as Retsevmo. |
| + | ==History of changes in Health Canada indication== | ||
| + | *2021-06-15: Initial notice of compliance with conditions as monotherapy for the treatment of metastatic RET fusion-positive [[Non-small cell lung cancer|non-small cell lung cancer (NSCLC)]] in adult patients. | ||
| + | *2021-06-15: Initial notice of compliance with conditions as monotherapy for the treatment of RET-mutant [[Thyroid cancer, medullary|medullary thyroid cancer (MTC)]] in adult and pediatric patients 12 years of age and older with unresectable advanced or metastatic disease. | ||
| + | *2021-06-15: Initial notice of compliance with conditions as monotherapy for the treatment of RET fusion-positive [[Thyroid cancer, differentiated|differentiated thyroid carcinoma]] in adult patients with advanced or metastatic disease (not amenable to surgery or radioactive iodine therapy) following prior treatment with sorafenib and/or lenvatinib. | ||
==Also known as== | ==Also known as== | ||
| Line 37: | Line 40: | ||
[[Category:EMA approved in 2021]] | [[Category:EMA approved in 2021]] | ||
[[Category:FDA approved in 2020]] | [[Category:FDA approved in 2020]] | ||
| + | [[Category:Health Canada approved in 2021]] | ||
Revision as of 01:42, 31 March 2023
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
- RET+ solid tumors (tissue-agnostic)
History of changes in FDA indication
Non-small cell lung cancer
- 2020-05-08: Granted accelerated approval for adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC). (Based on LIBRETTO-001)
- 2022-09-21: Granted regular approval for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a rearranged during transfection (RET) gene fusion. (Based on LIBRETTO-001)
RET (tissue-agnostic)
- 2022-09-21: Granted accelerated approval for adult patients with locally advanced or metastatic solid tumors with a rearranged during transfection (RET) gene fusion that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options. (Based on LIBRETTO-001)
Thyroid cancer
- 2020-05-08: 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)
- 2020-05-08: 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
- 2021-02-11: Initial conditional authorization as Retsevmo.
History of changes in Health Canada indication
- 2021-06-15: Initial notice of compliance with conditions as monotherapy for the treatment of metastatic RET fusion-positive non-small cell lung cancer (NSCLC) in adult patients.
- 2021-06-15: Initial notice of compliance with conditions as monotherapy for the treatment of RET-mutant medullary thyroid cancer (MTC) in adult and pediatric patients 12 years of age and older with unresectable advanced or metastatic disease.
- 2021-06-15: Initial notice of compliance with conditions as monotherapy for the treatment of RET fusion-positive differentiated thyroid carcinoma in adult patients with advanced or metastatic disease (not amenable to surgery or radioactive iodine therapy) following prior treatment with sorafenib and/or lenvatinib.
Also known as
- Code name: LOXO-292
- Brand names: Retevmo, Retsevmo