Sotorasib (Lumakras)

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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