Difference between revisions of "Sotorasib (Lumakras)"
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From the [https://www.cancer.gov/publications/dictionaries/cancer-drug/def/sotorasib NCI Drug Dictionary]: An orally available agent that targets the specific KRAS mutation, p.G12C, with potential antineoplastic activity. Upon oral administration, sotorasib selectively targets the KRAS p.G12C mutant, at either the DNA, RNA or protein level, and prevents, through an as of yet not elucidated manner, expression of and/or tumor cell signaling through the KRAS p.G12C mutant. This may inhibit growth in KRAS p.G12C-expressing tumor cells. | From the [https://www.cancer.gov/publications/dictionaries/cancer-drug/def/sotorasib NCI Drug Dictionary]: An orally available agent that targets the specific KRAS mutation, p.G12C, with potential antineoplastic activity. Upon oral administration, sotorasib selectively targets the KRAS p.G12C mutant, at either the DNA, RNA or protein level, and prevents, through an as of yet not elucidated manner, expression of and/or tumor cell signaling through the KRAS p.G12C mutant. This may inhibit growth in KRAS p.G12C-expressing tumor cells. | ||
| − | == | + | ==Diseases for which it is established== |
| − | *'' | + | *[[Non-small cell lung cancer, KRAS-mutated]] |
| + | |||
| + | ==Diseases for which it is used== | ||
| + | *[[Pancreatic cancer]] | ||
| + | |||
| + | ==History of changes in FDA indication== | ||
| + | *2021-05-28: Accelerated approval for adult patients with [[Biomarkers#KRAS|KRAS]] [[Biomarkers#G12C|G12C-mutated]] locally advanced or metastatic [[Non-small cell lung cancer|non-small cell lung cancer (NSCLC)]], as determined by an FDA-approved test, who have received at least one prior systemic therapy. ''(Based on CodeBreaK100<sub>NSCLC</sub>)'' | ||
| + | |||
| + | ==History of changes in EMA indication== | ||
| + | *2022-01-06: Initial conditional authorization as Lumykras. | ||
| + | ==History of changes in Health Canada indication== | ||
| + | *2021-09-10: Initial notice of compliance with conditions for the treatment of adult patients with Kirsten rat sarcoma viral oncogene homolog (KRAS) G12C-mutated locally advanced (not amenable to curative therapy) or metastatic [[Non-small cell lung cancer|non-small cell lung cancer (NSCLC)]] who have received at least one prior systemic therapy. | ||
| + | ==History of changes in PMDA indication== | ||
| + | *2022-01-20: Newly indicated for the treatment of unresectable advanced or recurrent KRAS G12C mutation-positive [[non-small cell lung cancer]] that has progressed after cancer chemotherapy. | ||
| + | ==Also known as== | ||
| + | *'''Code name:''' AMG-510 | ||
| + | *'''Brand name:''' Lumakras, Lumykras | ||
[[Category:Drugs]] | [[Category:Drugs]] | ||
[[Category:Oral medications]] | [[Category:Oral medications]] | ||
[[Category:KRAS inhibitors]] | [[Category:KRAS inhibitors]] | ||
| + | [[Category:Mutation-specific medications]] | ||
| + | |||
| + | [[Category:Non-small cell lung cancer medications]] | ||
| + | [[Category:Pancreatic cancer medications]] | ||
| − | [[Category: | + | [[Category:FDA approved in 2021]] |
| + | [[Category:Health Canada approved in 2021]] | ||
| + | [[Category:EMA approved in 2022]] | ||
| + | [[Category:PMDA approved in 2022]] | ||
Latest revision as of 02:12, 1 March 2024
Mechanism of action
From the NCI Drug Dictionary: An orally available agent that targets the specific KRAS mutation, p.G12C, with potential antineoplastic activity. Upon oral administration, sotorasib selectively targets the KRAS p.G12C mutant, at either the DNA, RNA or protein level, and prevents, through an as of yet not elucidated manner, expression of and/or tumor cell signaling through the KRAS p.G12C mutant. This may inhibit growth in KRAS p.G12C-expressing tumor cells.
Diseases for which it is established
Diseases for which it is used
History of changes in FDA indication
- 2021-05-28: Accelerated approval for adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test, who have received at least one prior systemic therapy. (Based on CodeBreaK100NSCLC)
History of changes in EMA indication
- 2022-01-06: Initial conditional authorization as Lumykras.
History of changes in Health Canada indication
- 2021-09-10: Initial notice of compliance with conditions for the treatment of adult patients with Kirsten rat sarcoma viral oncogene homolog (KRAS) G12C-mutated locally advanced (not amenable to curative therapy) or metastatic non-small cell lung cancer (NSCLC) who have received at least one prior systemic therapy.
History of changes in PMDA indication
- 2022-01-20: Newly indicated for the treatment of unresectable advanced or recurrent KRAS G12C mutation-positive non-small cell lung cancer that has progressed after cancer chemotherapy.
Also known as
- Code name: AMG-510
- Brand name: Lumakras, Lumykras