Difference between revisions of "Sotorasib (Lumakras)"
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==History of changes in FDA indication== | ==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)'' |
==History of changes in EMA indication== | ==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. | ||
==Also known as== | ==Also known as== | ||
*'''Code name:''' AMG 510 | *'''Code name:''' AMG 510 | ||
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[[Category:Non-small cell lung cancer medications]] | [[Category:Non-small cell lung cancer medications]] | ||
| − | + | [[Category:FDA approved in 2021]] | |
| + | [[Category:Health Canada approved in 2021]] | ||
[[Category:EMA approved in 2022]] | [[Category:EMA approved in 2022]] | ||
| − | |||
Revision as of 13:15, 30 March 2023
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 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 CodeBreaK100)
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.
Also known as
- Code name: AMG 510
- Brand name: Lumakras, Lumykras