Regulatory approval

Published by the Health Canada. Approved

Health Canada approved sotorasib 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.

This is written in the approval document as:

LUMAKRAS (sotorasib) is indicated 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.

Citation

Amgen Canada Inc. Lumakras (sotorasib) [product monograph]. Health Canada website. https://pdf.hres.ca/dpd_pm/00078781.PDF. Revised March 2025. Accessed June 2025.

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Organizations	Biomarkers	Cancer types	Therapies
HC (1)	KRAS p.G12C	Non-Small Cell Lung Cancer	Sotorasib

Contributions

Date	Contributor	Description
2024-10-30	Van Allen lab	Initial access of FDA approvals